Clinical Program Manager

3 weeks ago

Bethesda, United States GAP Solutions, Inc. Full time

Provide services as a Clinical Program Manager (Quality Auditor) 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**:

- Support the VRC CTP’s Quality Management Program under leadership of the Quality Program Manager, to ensure quality throughout all stages of the clinical trial process.
- Plan and conduct GCP sponsor audits (international and domestic) of clinical sites, contract clinical laboratories, and CROs to verify and document compliance status and identify any compliance risks.
- Assess GCP compliance risk areas and develop and implement risk mitigation measures.
- Ensure staff and program compliance with CTP’s quality procedures and regulatory requirements.
- Conduct trial master file audits.
- Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
- Serve on NIAID-wide working groups in support of NIAID’s broader development and implementation of a QMS.
- Provide support to federal clients in their evaluation and selection of CROs and other clinical and nonclinical service providers supporting CTP activities.
- Provide guidance, interpretation and information on GCP-related regulations, standards, and quality systems.
- Develop and implement SOPs, policies, work instructions, and other controlled documents for GCP regulatory compliance.
- Proactively identify areas for improvement, collaborate with QA and GCP staff and seek appropriate resources for the functioning and continuous improvement of the QMS.
- Conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting.

**Basic Qualifications**:

- Master’s degree in a related field is required.
- Minimum of two (2) years of experience in clinical research with Government, Biotech, Pharma and/or CRO and at least two (2) years of experience in Quality Systems related to GCP.
- Strong understanding of domestic and international quality and regulatory requirements and ICH/GCP is required.
- Experience auditing clinical CRO’s, clinical sites and investigator sites is required.

**Minimum Qualifications**:

- Certified quality auditor is preferred.
- Outstanding communication skills (interpersonal, verbal and written).
- Strong experience independently managing complex projects.
- 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.

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