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 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.

Clinical Trial Associate 

Summary

We are currently interviewing for an office based Clinical Trial Associate.  This position provides support to the Clinical Operations and Project Management departments through the performance of project-specific tasks whereby contributing to the overall management of clinical trials.  This full time position will be based in the Agility Carlsbad office and provides growth opportunities for the right candidate.

No relocation will be provided.

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.
  • Assists with the set-up of the eTMF system, including the creation of folders, updates to documents, inputting site information, QC of documents and running reports.
  • 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.
  • 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
  • Support the project team to ensure successful activation of trials sites according to time, quality/scope and budget parameters.
  • Liaise with Internal and External customers/vendors to meet project specific goals and Client deliverables.
  • Responsible for the creation of study binders for the clinical sites (e.g. ISF, SRM, etc.)
  • As required by certain projects, support Clinical Team Lead in the management of investigational sites to ensure compliance with the trial protocol, ICH-GCP and applicable regulations.
  • Assists in documenting departmental processes and designing related forms and templates.
  • 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 approximately 1 year of applicable experience, or equivalent combination of education and 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.

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, 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.

Proposal Development Specialist – Clinical

Proposal Development Specialists are responsible for timely generation of client facing project budgets, detailed proposals, and request for information (RFI) responses.

This opportunity is based out of our Carlsbad, CA office. Relocation assistance is available.

Essential duties:

  • Review RFIs, and prepare quality RFI responses
  • Review Requests for Proposal (RFPs) and prepare high quality proposals that address all aspects required by clients, including budget, timeline, and scope of work
  • Work closely with clients, senior management, and other internal team members to prepare budgets and proposals.
  • Liaise with third party vendors for bids for proposals
  • Participate in and lead proposal strategy and bid defense meetings, as needed
  • Facilitate smooth transition to the project team after project award
  • Ensure proposals and contracts information is processed into and maintained in relevant tracking databases
  • May participate in development/modification of department tools and procedures
  • May assist with contracts including CDAs, MSAs, work orders, vendor/consultant contracts, CTAs, etc.
  • May assist with company marketing / sales initiatives as needed
  • Perform other tasks as needed

Qualifications:

Minimum requirement:

  •  BA/BS degree

Other required:

  • Previous CRO or clinical research experience
  • 2+ years of experience in study budget and proposal development, or direct project experience (e.g., Clinical Project Management) within the CRO/Biopharma environment; or equivalent combination of education, training and experience
  • Ability to interpret RFIs, RFPs, and protocols
  • Comfort writing and talking across multiple functional areas in relation to clinical trials
  • Demonstrated ability to write and edit technical content
  • Experience creating a budget
  • Demonstrated history working independently and as part of a collaborative team
  • Able to digest instructions without deviating from precise directions
  • Strong communication, analytical and multi-tasking skills
  • History of developing high quality proposals that meet client and project needs while adhering to Agility’s internal established guidelines.
  • Dependable, prompt, reliable and personable
  • Travel expected as required

Preferred:

  • Four year degree with concentration in life sciences or related field of study
  • Exceptional problem solving skills
  • Proficiency in Microsoft Excel, Word, and Outlook
  • Ability to maintain effective working relationships with clients and coworkers
  • Strong organizational skills
  • Flexibility in responding to job demands
  • Comfortable managing multiple client engagements simultaneously and independently defining priorities based on goals and objectives.
  • Self-motivated, results oriented professional, who enjoys partnering across functions to execute on strategic priorities.

To apply for this positions, please email us your CV at Jobs_16218@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.

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.