Career Opportunities2018-07-24T20:08:14+00:00

Agility Clinical is a small, but growing consulting and clinical research organization focused on conducting clinical trials for virtual, small biopharma and device companies, particularly those working on therapies for orphan diseases. We have a great working environment offering opportunities for advancement for individuals with the right skills, initiative and motivation. If you are customer service oriented and have a passion for making a difference, then Agility may be the place for you.

We are currently looking to fill the following positions:

Biostatistician

We are seeing a highly-motivated Biostatistician to join Agility Clinical, Inc. This position provides statistical support for all phases of clinical development. Specific responsibilities include reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs.

SCOPE AND RESPONSIBILITIES:

  • Generate randomization schedules.
  • Provide sample size calculations.
  • Provide input into development of case report forms (CRFs).
  • Author statistical analysis plans, including development of table and listing shells.
  • Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.
  • Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Provide statistical analysis and reports to Data Monitoring Committees (DMCs).
  • Review output across programs to ensure consistency
  • Prepare statistical sections of clinical study reports.

DESIRED SKILLS & EXPERIENCE

  • MS or degree in Statistics.
  • Knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
  • Experience with SAS.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Clinical Data Coordinator

We are currently interviewing for a Clinical Data Coordinator for full time or part time positions at various levels. As a Clinical Data Coordinator, you will be responsible for assisting in managing one or more clinical trial databases for clinical trials, working with a variety of data management systems. As part of a project team, your areas of responsibility include assisting with CRF design, data management plans, database development, database quality control, medical coding, data review, clinical site training and database close activities.

DESIRED SKILLS & EXPERIENCE

  • Bachelor’s degree in a clinical, scientific, or related field, or equivalent work experience required.
  • Experience with Microsoft Office products (Outlook, Microsoft Word, Excel, Powerpoint)
  • Excellent communication and interpersonal skills to effectively interface with others in a team setting.
  • Excellent organizational skills, attention to detail, and a customer service demeanor.

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Clinical Data Manager / Senior Clinical Data Manager

As a Clinical Data Manager, you will be responsible for managing one or more clinical trial databases for clinical trials, working with a variety of data management systems.

JOB SUMMARY

The Clinical Data Manager is responsible for performing standard work functions in the areas of both clinical operations and data management.

JOB DUTIES & RESPONSIBILITIES

  • Manage clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines and regulatory agency guidelines.
  • Management of all data-related tasks required to manage clinical data.
  • Responsible for the creation, updating, maintenance and validation of clinical study databases and for the provision of computerized reports of these data.
  • Key member of the clinical project team working directly with the clinical Project Manager and/or Director and should be able to prioritize work in line with project management decisions.
  • Work with the clinical Project Manager and/or Director to ensure oversight of the data management portion of the study budget, ensuring project remains within scope and that any out of scope activities are identified and handled as appropriate.
  • CRF design and associated completion guideline instructions according to standard operating procedures and protocol.
  • Data Management Plan development including diagnostic writing and data flow definition through database lock according to standard operating procedures and protocol.
  • Perform user acceptance testing.
  • Patient and study level status/metric reporting.
  • Dictionary coding (MedDRA and WhoDrug).
  • Review, analyze, and validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
  • Assist in standardizing data management procedures such as documentation for departmental standard operating procedures.
  • Maintain clinical trial data accuracy through review of case report forms for completeness and consistency.
  • Assist in the development and implementation of strategy for data cleaning and in the design and programming of clinical databases.
  • Query data inconsistencies in compliance with standard operating procedures, client guidelines and regulatory agency guidelines.
  • Generate data retrievals and summaries.
  • Assists with review of clinical study reports.
  • Ability to fulfill a variety of data-related roles while building company strength and experience in data activities.
  • Interacts with internal work groups to evaluate needs, resources and timelines.
  • Reviews and provides input to standard operating procedures when required.
  • Mentors, and trains staff at a functional level
  • Performs other duties as assigned by management.

QUALIFICATIONS:

Required

  • Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline.
  • Broad knowledge of drug development and effective clinical data management practices.
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook and EDC systems.
  • Ability to handle a variety of clinical research tasks.
  • Excellent organizational and communication skills.
  • Professional use of the English language; both written and oral.
  • Minimum of five (5) years in clinical operations, data management or related discipline in the CRO/pharmaceutical industry with at least three (3) years of experience in data management.
  • Understanding of clinical operations financial management practices including budget, scope of work and task achievement.
  • Management of third-party vendor data.
  • Understanding of CDISC standards.
  • Experience with one or more EDC systems

Preferred

  • Dictionary coding (MedDRA and WhoDrug).

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Clinical Research Associate/ Sr. CRA

We currently are interviewing for office and home (regional) based CRAs in all therapeutic areas to join our team. A broad range of CRA experience is highly desirable.

CRAs are responsible for monitoring the progress of clinical studies at investigative sites, and ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

SCOPE AND RESPONSIBILITIES

  • Independent and proactive coordination of all necessary activities required to set up and monitor a study (i.e., identify investigators; help prepare regulatory submissions, conduct pre-study and initiation visits, etc.).
  • Identify, select, initiate and close out appropriate investigational sites for clinical studies. You will monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with Agility SOPs, applicable regulations and the principles of ICH-GCP.
  • Approximately 50-70% travel overall can be expected, national and regional travel. The goal at Agility is to keep travel as regional as possible.

DESIRED SKILLS & EXPERIENCE

  • Undergraduate degree in a clinical, scientific, or related field, or equivalent work experience required (RN or LPN with at least 4 years of recent field monitoring experience).
  • Applicants must have at least 2 years of experience independently monitoring clinical trials for drug studies.
  • Experience monitoring EDC trials are preferred.
  • Excellent communication and organizational skills are essential.
  • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
  • Ability to travel overnight, primarily in the U.S., 3 days per week on average.
  • Will consider CRAs for a home-based office if he/she has at least 6 months of verifiable home-based experience and high-speed connectivity in the home office as part of above qualifications.
  • Excellent communication and interpersonal skills to effectively interface with others.
  • Independent contractors are encouraged to apply

To apply for this positions, please email us your CV at Jobs_16225@agility-clinical.com and place the job title in the subject line.

Drug Safety And Pharmacovigilance Professional

This is an exciting opportunity for a qualified individual interested in joining a growing safety surveillance and pharmacovigilance group that supports drug development for orphan and ultra‑orphan diseases and disorders. The title and level of responsibility will be commensurate with the candidate’s qualifications and previous experiences in safety and pharmacovigilance.

Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.

In addition, the safety specialist/safety manager will contribute to; signal detection activities, the preparation of aggregate safety reports (DSUR, PADER, and PSUR) and the review of medical coding for consistency and medical accuracy.

Education Level and Requirements for the Position

  • Health care professional (nursing or pharmacy degree preferred)
  • Minimum of 3 years of clinical and/or study coordinator experience; industry experience in CRO or pharmaceutical company preferred
  • Hands on experience with global safety database(s), SAE case processing, and safety reports generation
  • Working knowledge of MedDRA and WHODrug
  • CRO and/or Pharma experience desirable, but not required

RESPONSIBILITIES AND DUTIES

Participate in safety services, including intake, triage, database case entry, preparation of narratives, follow up and query resolution with sites

Work with clients and project teams to prepare and/or review project‑specific safety reporting plans, including safety management plans, safety data review reports, aggregate data reports (PSUR, DSUR, PADER), signal detection outputs, etc.

Assist clients and colleagues with signal detection activities and safety-related reviews, including preparation of information for independent safety review and data monitoring committees

Follow Agility Clinical policies and procedures as well as applicable regulations.

To apply for this positions, please email us your CV at Jobs_16227@agility-clinical.com and place the job title in the subject line.

Manager, Biostatistics

This essential team member will be responsible for leading the biostatistics efforts for specific projects and studies, including reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs. In addition, this team member will be responsible for managing resources within the Biostatistics and Statistical Programming department. As part of the Biostatistics team, this person will also provide technical expertise to the development of programming standards and procedures. Relocation assistance will be considered.

SCOPE AND RESPONSIBILITIES:

  • Manage employees within Biostatistics functional area.
  • Develop and maintain departmental procedures and standards.
  • Assist with project forecasting and resourcing needs through a combination of internal and external resources.
  • Hire, train, guide career growth, and provide development opportunities for Biostatisticians.
  • Provide oversight for assigned projects.
  • Provide technical oversight and leadership in the areas of analysis and reporting.
  • Generate randomization schedules.
  • Provide sample size calculations and assist in protocol development.
  • Provide input into development of case report forms (CRFs).
  • Author statistical analysis plans, including development of table and listing shells.
  • Review statistical analysis plans written by other Biostatisticians.
  • Write analysis plans for eCTD submissions (eg, ISS and ISE)
  • Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.
  • Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Provide statistical analysis and reports to Data Monitoring Committees (DMCs).
  • Review output across programs to ensure consistency.
  • Prepare statistical sections of clinical study reports.
  • Interact directly with clients.
  • Assist in SOP creation/review and associated forms and templates.
  • Participate in the development and/or maintenance of departmental procedures and standards

DESIRED SKILLS & EXPERIENCE

  • MS degree in Statistics and a minimum of 5 years of relevant industry experience
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
  • Excellent communication and interpersonal skills to effectively interface with others

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Manager, Clinical Data Management

We are currently interviewing for experienced Clinical Data Management professionals for full time and part time positions at various levels. As a Manager, Data Management, you will be responsible for managing one or more direct reports in addition to managing one or more clinical trial databases for clinical trials, working with a variety of data management systems. As part of a project team, your areas of responsibility include management/supervision, CRF design, data management plans, database development, database quality control, medical coding, data management process and documentation development, data review, site training, database close and quality control audits. Potential for learning and participating in activities in other functional areas.

DESIRED SKILLS & EXPERIENCE

  • Bachelor’s degree in a clinical, scientific, or related field, or equivalent work experience required.
  • Applicants must have at least 8-10 years of experience in a biopharmaceutical company or CRO.
  • Experience with one or more EDC systems required.
  • Experience with Microsoft Office Products (Outlook, Word, Excel, Powerpoint, Access)
  • Excellent communication and interpersonal skills to effectively interface with others in a team setting.
  • Excellent organizational skills, attention to detail, and a customer service demeanor.

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Manager, Clinical Operations

We currently are interviewing for experienced office and home (regional) based managers. This team member will serve as the clinical team lead responsible for the planning, conduct and oversight of the operational portion of clinical studies, ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. This team member will also be responsible for managing one or more direct reports and providing oversight of training, performance and career management.

SCOPE AND RESPONSIBILITIES

  • Manage employees and/or contractors within the Clinical department.
  • Develop and maintain departmental procedures and standards.
  • Assist with project forecasting and resourcing needs through a combination of internal and external resources.
  • Hire, train, guide career growth, and provide development opportunities for Clinical employees.
  • Drive and manage the clinical and site management aspects of assigned studies.
  • Develop and maintain study plans, guidelines and tools.
  • Track and review monitoring reports.

DESIRED SKILLS & EXPERIENCE

  • Bachelor’s degree in a clinical, scientific, or related field, or equivalent work experience required
  • Applicants must have at least 8 years of experience in a biopharmaceutical company or CRO
  • Moderate independent field monitoring experience
  • Clinical team lead or comparable supervisory experience
  • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
  • Excellent communication and interpersonal skills to effectively interface with others in a team setting
  • Excellent organizational skills, attention to detail, and a customer service demeanor

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Manager, Safety

Safety Managers are responsible for providing safety services for Agility clients including the development of project specific plans for the collection, triage, processing, and medical coding of adverse event (AE) data associated with clinical trials and/or post-marketing safety surveillance, and the management and development of safety staff.

This opportunity is based in our Carlsbad, CA office.

Essential duties:

  • Prepare and/or review project‑specific safety management plans
  • Provide safety services, including intake and triage of AEs, safety case processing, and writing comprehensive medical narratives and analyses of similar events (AOSEs) for expedited reporting
  • Prepare and/or review of safety training materials
  • Manage, train and mentor staff, consultants, and/or contractors
  • Provide oversight of project deliverables
  • QC of documents and safety reports
  • Review and/or draft standard operating procedures and work instructions
  • Review of clinical data or data from the published literature
  • Prepare and/or review of project‑specific medical coding plans
  • Participate in medical coding processes
  • Participate in the coaching and development of direct reports by providing an environment that encourages ongoing personal and professional development
  • Plans, coordinates and manages internal and external safety resources to accomplish assignments to the highest quality standards within the given deadlines.

Qualifications:

Minimum requirement:

  • Bachelor’s degree in life sciences

Other required:

  • Minimum of 8 years of experience in safety in the CRO or pharmaceutical industry; minimum of 2 years in managerial role in drug safety
  • Solid knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
  • Experience with case processing in ARGUS and/or ARISg
  • Demonstrated ability to challenge existing practices in order to become more effective.
  • Ability to effectively adapt to a variety of situations
  • Works while meeting quality and performance standards
  • Strong influencing skills
  • Excellent communication skills, both written and oral
  • Works effectively as a team member and promotes collaboration
  • Demonstrates ownership, initiative and accountability
  • Supervisory experience
  • Approximately 15% travel

Preferred:

  • Clinical experience highly desirable, but not required

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Manager, Statistical Programming

This essential team member will be responsible for leading the SAS statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project’s needs. In addition, this team member will be responsible for managing resources within the Biostatistics and Statistical Programming department. As part of the Statistical Programming team, this person will also provide technical expertise to the development of programming standards and procedures.

SCOPE AND RESPONSIBILITIES:

  • Manage employees and/or contractors within the Statistical Programming functional area.
  • Develop and maintain departmental procedures and standards.
  • Assist with project forecasting and resourcing needs through a combination of internal and external resources.
  • Hire, train, guide career growth, and provide development opportunities for Statistical Programmers.
  • Provide oversight for assigned projects.
  • Provide technical oversight and leadership in the areas of analysis and reporting• Program and/or QC datasets, tables, listings, and figures using SAS.
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports)
  • Generate SDTM domains, ADaM datasets, and Define.xml files
  • Oversee CDISC dataset compilation for creation of Define.xml and/or Define.pdf.
  • Document the quality control review process
  • Review output across programs to ensure consistency
  • Work with data management personnel on projects to identify database issues.
  • Assist in SOP creation/review and associated forms and templates.
  • Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
  • Program, test, and document global utility programs and tools in accordance with standards and validation procedures
  • Participate in the development and/or maintenance of departmental procedures and standards
  • Review CRFs, edit check specifications, and table mock-ups

DESIRED SKILLS & EXPERIENCE

  • BS degree in Statistics, Mathematics, or Computer Science or in a related field
  • Minimum of 7 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
  • Excellent communication and interpersonal skills to effectively interface with others
  • Independent contractors are encouraged to apply

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Project Manager/ Sr. Project Manager

We currently are interviewing for Project Managers to join our team. The project manager plans, directs, coordinates, and delivers activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.

SCOPE AND RESPONSIBILITIES

  • Reviews project plan to determine time frame, procedures for accomplishing project, and staffing requirements.
  • Acts as liaison between sponsor and in-house project team members to ensure that project needs are met.
  • Confers with project staff to define objectives, outline work plan, and assign duties and responsibilities.
  • Identifies critical path of the project and communicates priorities to the project team.
  • Coordinates and manages all functional groups assigned to the project..
  • Develops and maintains timelines and supervises project team activities to ensure that project is accomplished on schedule and within budget.
  • Initiates project progress meetings, tracks project progress, and reports to senior management and sponsors, as required.
  • Encourages good working relationships across projects.
  • Assures that all aspects of project are performed in compliance with standard operating procedures (SOPs), client SOPs (if applicable), and International Conference on Harmonisation (ICH) and Good Clinical Practices (GCP) guidelines, and local laws where applicable.
  • Reviews and maintains project documents, files, and correspondence.
  • Assesses strengths and weaknesses of project at completion, and applies lessons learned to next project.
  • Assists Business Development group with contract/proposal preparation.
  • Assists in the formation of project teams for specific projects.
  • Assists in the performance review of project team members by reporting feedback to functional managers.

DESIRED SKILLS & EXPERIENCE

  • Bachelor’s degree in life sciences or related field and 6-8 years clinical research experience including 2-4 years of direct project management experience and experience in clinical operations; or equivalent combination of education, training and experience.
  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
  • Good therapeutic and protocol knowledge
  • Strong communication and interpersonal skills, including good command of English language
  • Good problem solving skills
  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics
  • Good teamwork skills
  • Excellent customer service skills
  • Good presentation skills
  • Good judgment
  • Strong software and computer skills, including MS Office applications
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Consultants are encouraged to apply

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

SAS Programmer

This essential team member will be responsible for supporting the SAS programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project’s needs.

SCOPE AND RESPONSIBILITIES:

  • Review CRFs, edit check specifications, and table mock-ups
  • Work with data management personnel on projects to identify database issues
  • Assists data management with programming of edit checks and other data management specific programming
  • Create specifications for derived/analysis datasets
  • Program analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
  • Generate SDTM domains, ADaM datasets, and Define.xml files
  • Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports)
  • Document the quality control review process
  • Review output across programs to ensure consistency
  • Review, maintain, and approve study documents per standard procedures

DESIRED SKILLS & EXPERIENCE

  • BS degree in Statistics, Mathematics, or Computer Science or in a related field.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Senior Biostatistician

We are seeing a highly-motivated Senior Biostatistician to join Agility Clinical, Inc. This position provides statistical support for all phases of clinical development. Specific responsibilities include reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs. This position reports to the Director of Biostatistics.

SCOPE AND RESPONSIBILITIES:

  • Generate randomization schedules.
  • Provide sample size calculations.
  • Provide input into development of case report forms (CRFs).
  • Author statistical analysis plans, including development of table and listing shells.
  • Review statistical analysis plans written by other Biostatisticians.
  • Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.
  • Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Provide statistical analysis and reports to Data Monitoring Committees (DMCs).
  • Review output across programs to ensure consistency.
  • Prepare statistical sections of clinical study reports.
  • Interact directly with clients.

DESIRED SKILLS & EXPERIENCE

  • MS or degree in Statistics and a minimum of 5 years of relevant industry experience.
  • Knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
  • Experience with SAS.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Senior Clinical Trial Associate / Senior In House Clinical Research Associate 

We are currently interviewing for an office based Senior Clinical Trial Associate. This position provides support to the Clinical Operations and Project Management department through the performance of project-specific tasks whereby contributing to the overall management of clinical trials. Will also provide a leadership and support to Clinical Trial Associates.

Essential Duties

  • Assist clinical study teams with all aspects of study management from study start-up to close-out on various studies simultaneously.
  • Assist with preparations of essential document templates, collection, and review. Perform study tracking to ensure that the study files are current, accurate and complete.
  • Create and maintain central study files for the duration of the study including assisting in file review and reconciliation for audits, in addition to preparing study files for archival.
  • Assist in planning, organizing and executing project-specific meetings including but not limited to Agility-Client meetings, CRA training meetings, and PI meetings.
  • May be responsible for non-drug supply tracking and shipping.
  • Process invoices and expense reports from regional CRAs which may include identification and resolution of questions to be brought to the Project Manager’s attention.
  • Ensure finalized Clinical Trial Agreements/Contracts are properly tracked, maintained, filed and forwarded to the sponsor/clinical sites.
  • Prepares correspondence, spreadsheets and presentations utilizing Microsoft Office Suite, for project specific studies. Develop and maintain project specific plans, documents and tools for the Clinical Team
  • Lead team of Clinical Trial Associates (CTA) to ensure appropriate site management, essential document compliance, corporate metric review and study coding accuracy during start-up, maintenance and close out phases of study.
  • Take initiative to lead/support the project team to ensure successful activation of trials sites according to time, quality/scope and budget parameters.
  • Collaborate with the Project Manager (PM) to facilitate cross functional team and sponsor communication for proactive, study-wide problem solving regarding study progress and trial issues during the study.
  • Liaise with Internal and External customers/vendors to meet project specific goals and Client deliverables.
  • As required by certain projects, support Clinical Team Manager/Lead in the management of investigational sites to ensure compliance with the trial protocol, ICH-GCP and applicable regulations.
  • Possibility to line manage Clinical Trial Associates.
  • May assist Sr. Management in the evaluation of software and systems.
  • Assists in documenting departmental processes and designing related forms and templates.
  • May assist with the writing and updating of SOPs.
  • Interview, train and mentor team members in Clinical Operations.
  • Arranges catering for department/company luncheons, client luncheons an occasionally dinner as necessary for project specific study team members.
  • May perform other duties as assigned.
  • Performs all duties in accordance with Agility Clinical’s SOPs, government regulations and Good Clinical Practices.

Knowledge, Skills and Abilities

  • High school diploma required, Associate Degree or equivalent college coursework in a related field of study preferred. Requires 1-2 years applicable experience, or equivalent combination of education an experience.
  • Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database.
  • Able to read an interpret documents such as safety rules, operating and maintenance instructions, an procedure manuals; to write routine reports an correspondence; to speak effectively before groups of customers or employees of organization.
  • Able to add, subtract, multiple, and divide in all units of measure, using whole numbers, common fractions, an decimals; to compute rate, ration an percent and to draw and interpret bar graphs.
  • Able to apply common sense understanding to carry out detailed but uninvolved written or oral instructions; to deal with problems involving a few concrete variables in standard situations.
  • Must possess a customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail.

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Senior Clinical Quality Assurance Associate

We’re looking for a Senior Clinical Quality Assurance Associate with clinical research and vendor audit experience to provide support in the implementation of our quality management system. Are you ready to be an integral part of a dynamic and growing clinical research organization in a company with diverse product offerings such as pharmaceutical, diagnostics and medical device?

About You:

  • You love traveling for business
  • You enjoy conducting a variety of vendor audits in both pharma and device trials
  • You love being in a consultative role where you can provide your GCP/ICH expertise to the team
  • You commonly focus on intricate details of a situation yet you are able to see the overall big picture
  • You enjoy establishing new groundwork in QA with risk based management strategies
  • You love being a mentor and a collaborator, sharing your knowledge to help grow and encourage peers and team members

Here are some of the high level aspects of the role:

  • Administer Quality Management System, including SOP, training, and CAPA systems
  • Host client/sponsor audits and regulatory inspections
  • Coordinate and conduct assessments of potential and contracted vendors, including vendor audits
  • Orchestrate and lead internal audits of quality systems, investigator site audits, trial master file audits and documentation audits
  • Develop and administer training for employees and consultants
  • Participate in computer systems validation projects and systems change control process
  • Provide QA consultation and support to assigned project teams internally and externally and according to defined quality oversight plans as applicable
  • Monitor quality systems to provide feedback on compliance risks to QA management and find opportunities for improvement

Qualifications:

Minimum Required:

  • Bachelor’s degree in a science, healthcare, or related field of study
  • Two to five years of applicable experience or equivalent combination of education and experience

Other Required:

  • Clinical research experience in non-QA role considered (e.g. clinical research associate experience)
  • Pharmaceutical and/or Medical device experience
  • Working knowledge of GCP/ICH guidelines and FDA regulations and standards
  • Travel requirement of up to 25-50%; domestic and international
  • Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database
  • Customer service demeanor, including proven collaboration and flexibility, teamwork, and a keen attention to detail
  • Excellent written and verbal interpersonal skills
  • Proven ability to work successfully both independently and in a team environment
  • Successful history working with cross functional groups and management under challenging situations
  • Shown ability to prioritize work and handle multiple and/or contending assignments

Preferred:

  • QA certification (e.g. CQA, SQA, etc.)
  • Experience with electronic clinical trial systems (e.g. EDC, CTMS, IxRS, ePRO, etc.)

Click here to apply.

Senior Director, Drug Safety & Pharmacovigilance

We are pleased to share this exciting opportunity for a Senior Director, Pharmacovigilance who is passionate about rare and orphan disease to join our growing business. As a member of our Senior Management team, you will have a blank slate when it comes to leading, developing and growing a new and innovative department.

Key safety services components focus will be on line management oversight, resourcing, business development, client project work and ARGUS.

About You:

  • You enjoy variety and knowing that no two days will ever be the same
  • You love seeing what you do every day impacts the lives of patients
  • You are a self-starter and enjoy taking calculated risks and pushing the boundaries of what others believe is possible
  • You are open-minded and always ask inquisitive questions that help you see things from various viewpoints and perspectives
  • You put your big-picture thinking and differentiating insights into effect daily
  • You successfully develop and cultivate relationships with business partners. Motivating and leading teams effectively comes natural to you

Here are some of the essential duties of the role:

  • Handles the provision of safety services for clients in compliance with federal regulations, ICH guidelines, Good Clinical Practices, company Standard Operating Procedures (SOP) and client contractual arrangements
  • Owns the multidisciplinary team completing the configuration, validation, and implementation process and the ongoing management of the related vendors and consultants for Argus and IRMS-AE
  • Runs the day-to-day operations of the Safety group and the safety case managers, e.g., preparing and delivering annual performance reviews; coaching and mentoring
  • Prepares for and participates in business development activities including attending bid defense meetings, proposal development and assigning of work
  • Works with client and internal project teams to identify and address project safety needs from start‑up activities through completion
  • Provides leadership, oversight and hands on assistance with safety case processing, preparation of project-related documents, safety tools, and safety information/tables and/or reports for clients and/or regulatory agencies
  • Contributes to the development of internal processes including SOPs, Guidelines and Work Instruction Documents
  • Provides consultation to clients or potential clients on safety requirements, including methods of safety data collection, processing, surveillance, and reporting for clinical studies and post-marketing projects
  • Prepares and/or reviews narratives for clinical study reports (CSRs) and safety training materials

Qualifications:

Minimum Required:

  • Bachelor’s degree

Other Required:

  • 12+ years of experience in safety in the CRO or pharmaceutical industry; minimum of 8 years in managerial role in drug safety
  • Proven knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations
  • Case processing in ARGUS and/or ARISg
  • Supervisory experience
  • Validated ability to challenge existing practices in order to become more effective.
  • Ability to effectively adapt to a variety of situations. Works while meeting quality and performance standards. Strong influencing skills, communication skills; both written and oral. Works effectively as a team member and promotes teamwork. Shown ownership, initiative and accountability
  • Approximately 20% travel

Preferred:

  • Nursing or pharmacy degree

Click here to apply.

Sr. Director, Project Management

We currently are interviewing for a Sr. Director, Project Management to join lead our Project Management Department. The Sr. Director of Project Management plans, directs, coordinates, and delivers activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Additionally, the Director will manage the team of associate directors, project managers and associate project managers.

SCOPE AND RESPONSIBILITIES:

  • Manage the department of project managers and associate project managers, including employees located in global offices worldwide.
  • Direct project forecasting and resourcing needs for the Project Management Department through a combination of internal and external resources.
  • Hire, train, guide career growth, and provide development opportunities for the Device and Diagnostic group.
  • Participates in Agility business development activities, including strategic input, leading capabilities and bid defense presentations. May travel to attend bid defense presentations and to meet with employees.
  • Work with business operations team to review/provide input to budgets and proposals for device and diagnostic business opportunities.
  • May attend trade shows or conferences
  • Responsible for the successful management of projects being conducted by Agility.  Assigned to manage the full range of projects; from small limited scope projects to full service, large scale, complex programs.
  • Primary interface with Client representatives, as well as Agility personnel in applicable functional departments, to ensure the timely initiation and completion of clinical trials.
  • Coordinates initial client meeting identifying project objectives.
  • Identifies potential risks including bottlenecks/delays; develops and executes contingency plans in order to keep the project on schedule.
  • Interacts with applicable pharmaceutical, biotechnology clients, vendors, and Agility personnel to ensure that all contractual obligations are met.
  • Coordinates Project Team Meetings, including meeting facilitation and development of meeting agendas and minutes.
  • Coordinates study specific training and other requirements for internal and external staff, as appropriate.
  • Manages budget throughout the duration of the project and develops out of scope documentation and costs.
  • Produces periodic reports as required to notify applicable stakeholders of project performance/status.
  • Contributes to the development and revision of Standard Operating Procedures (SOPs) and departmental policies.
  • May included periodic travel to client meetings, bid defenses, meetings with employees and conferences as needed.
  • May be required to lead or attend teleconferences outside of normal business hours.
  • May perform other duties as assigned.
  • Adheres to applicable ethical, regulatory, and clinical standards.
  • Follow applicable regulations, including FDA, ICH, and Agility Clinical Policies and Procedures.

DESIRED SKILLS & EXPERIENCE

  • Bachelor’s degree in life sciences or related field and 10-15 years clinical research experience including 8 years of direct project management experience in and experience in clinical operations; or equivalent combination of education, training and experience.  Prefer experience in leading and managing a department such as Project Management or Clinical Operations.
  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
  • Good therapeutic and protocol knowledge
  • Strong communication and interpersonal skills, including good command of English language
  • Good problem solving skills
  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics
  • Good teamwork skills
  • Excellent customer service skills
  • Good presentation skills
  • Good judgment
  • Strong software and computer skills, including MS Office applications
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Consultants are encouraged to apply

To apply for this positions, please email us your CV at Jobs_16229@agility-clinical.com and place the job title in the subject line.

Senior Director Regulatory Affairs

We are currently seeking an experienced regulatory professional to oversee the Regulatory Affairs function in support of clients developing regulated products, for training of staff and for development of departmental processes in compliance with government regulations concerning investigational and approved products, ICH Guidelines, Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs).  This position involves strategic planning and communications with clients, regulatory authorities, and Agility personnel (employees and consultants).

SCOPE AND RESPONSIBILITIES:

  • Responsible for maintaining up-to-date knowledge of regulations, guidelines and pharmaceutical industry standards and practices with regard to regulated product development.
  • Responsible for authoring and/or reviewing SOPs for regulatory processes at Agility.
  • Responsible for ensuring that project deliverables comply with applicable regulations, guidelines, SOPs, and/or client‑specific formats, as applicable.
  • Responsible for preparing or overseeing the preparation of documents for regulatory submission, e.g., regulatory meeting requests, Information Packages, INDs, IND amendments, Annual Reports, DSURs, PSURs, NDAs, ANDAs, and applications for Orphan Drug
  • Designation, Fast Track Designation, Breakthrough Therapy Designation.
  • Experience with preparing documents for electronic submissions.

DESIRED SKILLS & EXPERIENCE

  • Minimum of 12 years of combined industry, regulatory agency, and/or academic experience.
  • CRO experience or working knowledge of CRO operations highly desirable.
  • In-depth knowledge of GCPs, ICH guidelines and FDA regulations.
  • Knowledge of US and global requirements with regard to regulatory submission processes and content requirements. Direct experience with the preparation of documents for regulatory submission.
  • Regulatory Affairs certification advantageous, but not required.
  • Intermediate proficiency in Microsoft Word, Microsoft Excel, and PowerPoint.
  • Demonstrated ability to plan, execute, control and deliver.
  • Ability to read, analyze, and interpret common scientific and technical journals, to respond to common inquires or complaints from regulatory agencies; to effectively present information to top management, public groups, and/or board of directors.
  • Able to define problems, collect data, establish facts, and draw valid conclusions; to interpret an extensive variety of technical instructions in mathematical or diagram form and to deal with several abstract an concrete variables.
  • Ability to evaluate regulations and electronic processes and requirements.
  • Must possess a professional demeanor, a customer service demeanor; demonstrate keen attention to detail, effective organization and time management skills, and the ability to communicate effectively.
  • Must possess the ability to multitask and manage multiple and changing priorities with adherence to deadlines.

To apply for this positions, please email us your CV at Jobs_16228@agility-clinical.com and place the job title in the subject line.

Senior Statistical Programmer

This essential team member will be responsible for supporting the SAS statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project’s needs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of programming standards and procedures.

SCOPE AND RESPONSIBILITIES:

  • Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data
  • Generate SDTM domains, ADaM datasets, and Define.xml files
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports)
  • Document the quality control review process
  • Review output across programs to ensure consistency
  • Review, maintain, and approve study documents per standard procedures
  • Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
  • Program, test, and document global utility programs and tools in accordance with standards and validation procedures
  • Provide technical oversight and leadership in the areas of analysis and reporting
  • Participate in the development and/or maintenance of departmental procedures and standards
  • Review CRFs, edit check specifications, and table mock-ups
  • Assist in creation of table mockups under supervision of statisticians
  • Serve as the primary project team representative, delegating work as appropriate
  • Train and mentor new programmers

DESIRED SKILLS & EXPERIENCE

  • BS degree in Statistics, Mathematics, or Computer Science or in a related field
  • Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
  • Excellent communication and interpersonal skills to effectively interface with others
  • Independent contractors are encouraged to apply

To apply for this positions, please email us your CV at Jobs@agility-clinical.com and place the job title in the subject line.

Agility Clinical appreciates recruiter interest; however, unsolicited resumes or calls from third parties will not be accepted at this time. Agility does not accept unsolicited resumes from outside recruiting firms. Any resume submitted in the absence of a signed agreement will become the property of Agility and no fee shall be due.