Position Objective: Provide services as a Project Manager (Clinical Trial Oversight) in support of the overall functions of the Vaccine Research Center (VRC), Clinical Trials Program (CTP) within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:

• Serve as a regulatory and clinical operations subject matter expert for the VRC, including advising on the regulatory process to meet FDA requirements and international site requirements.
• Oversee and coordinate activities necessary to ensure effective and efficient operations of the Advanced Clinical Development Unit (ACDU).
• Assist ACDU Chief and CTP/VRC Leadership in clinical, regulatory, pharmacy, laboratory and support program planning, development and implementation of external VRC-sponsored studies.
• Collaborate in the oversite of data management, site management, and site monitoring activities for VRC-sponsored clinical research studies.
• Work closely with the ACDU Chief and subject matter experts to ensure timely review of clinical trial reports, deliverables and data; collaboratively evaluate and provide feedback, recommendations and follow up to ensure compliance and consistency with VRC policies, protocol and study procedures, and regulatory/GCP requirements; implement strategies to mitigate identified risks.
• Support the ACDU Chief in tracking timelines, performance metrics and resource utilization of clinical trials.
• Develop and provide relevant program status reports to the ACDU Chief and CTP/VRC Leadership as requested.
• Provide support and expertise to internal and contract support (CRO) study team members regarding trial-related questions or problems, clinical trial site oversight, regulatory documentation, and clinical data management.
• Mentor and train team members.
• Serve as support for senior management and facilitate the overall operations of externally conducted clinical trials.
• Serve as a liaison on matters with intramural and extramural collaborators and program officials at NIAID on joint vaccine development projects.
• Communicate regulatory and clinical operations strategy effectively with high-level scientists, physicians, managers, and administrators, as well as with consultants, and other interested parties.
• Assist in the review of site evaluations, site selection decisions, implementation of trials at sites and site audits.
• Identify issues that are problematic or potentially problematic and make recommendations working jointly with federal CTP Team Leads to identify resolutions.
• Create workflow and project management templates that can be used for tracking key milestones or identify potential problems in critical path milestones which could delay mission critical projects.
• Organize and maintain files on activities, site visit reports, and milestones from the various grants, contracts, cooperative agreements, and interagency agreements that impact the work unit.
• Serve as a financial and/or scientific and technical subject matter resource for the ACDU and other teams for the Clinical Trials Program.
• Assist ACDU Chief with the management and tracking of reports and documents (timelines, protocols, standard operating procedures, manuals of operations, protocol updates, source documents, gap analysis, cost estimates, etc.) for projects managed internally or under scientific contracts.
• Support regular meetings of the ACDU through coordination, editing minutes and tracking action items.
• Provide the Task Leader with additional scientific, technical, and project management expertise.
• Review and comment on invoices to help Contracting Officer’s Representatives account for fiscal resources; develop and maintain invoice tracking system to account for fiscal resources.
• Review and edit documents and make recommendations to the Task Leader.
• Participate in clinical site visits, vendor audits, and other meetings with internal and external collaborators.
• Oversee and coordinate CTP efforts in creating and maintaining Trial Master Files, ensuring essential documents are inspection ready.
• Serve as a subject matter resource on the CTP Quality Management team, and as a CTP representative on NIAID-wide Quality Management teams and initiatives.
• Serve as a subject matter resource on the CTP Oversight Monitoring team.
• Serve as a subject matter resource on the CTP Pharmacovigilance Team.

Basic Qualifications:

• BS degree in a scientific or clinical field is required.
• Minimum 15 years’ experience in clinical research within Government, Biotech, Pharma and/or CRO and at least 5 years’ experience in Quality Systems related to ICH/GCP.
• Experience evaluating and/or auditing clinical CROs and clinical sites.
• Strong understanding of domestic and international quality and regulatory requirements and ICH/GCP.

Minimum Qualifications:

• Outstanding communication skills (interpersonal, verbal and written).
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects.

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.