Clinical Program Manager

(ID: 2024-5265)

Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Benefits:

100% Medical, Dental & Vision Coverage for Employees

Paid Time Off (Including Holidays)

Employee Referral Bonus

401K Match

Tuition reimbursement and professional development opportunities

Flexible Spending Accounts:

Healthcare (FSA)

Parking Reimbursement Account (PRK)

Dependent Care Assistant Program (DCAP)

Transportation Reimbursement Account (TRN)

Overview

Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Program Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Clinical Trials Program (CTP).

Technical Requirements:

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.

Specific 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.

Certified quality auditor is preferred.

Experience auditing clinical CRO’s, clinical sites and investigator sites is required.

Strong understanding of domestic and international quality and regulatory requirements and ICH/GCP is required.

Outstanding communication skills (interpersonal, verbal and written).

Strong experience independently managing complex projects.

The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact:

Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.