Clinical Trial and Pharmacovigilance Operations Manager Jobs

Role Overview Department of Defense is hiring a Clinical Trial and Pharmacovigilance Operations Manager in Frederick, Maryland, US. This full‑time entry‑level role requires managing safety pharmacovigilance for FDA‑regulated clinical trials and emergency use applications. Duties Manage all aspects of safety pharmacovigilance (PV) for FDA‑regulated clinical trials and emergency use applications across various disease areas and research programs. Perform sponsor’s assessment of adverse event reports for seriousness, expectedness, and causality; determine FDA reporting requirements; maintain serious adverse event safety database. Ensure studies are conducted in compliance with protocol, current Good Clinical Practices (cGCP), and relevant regulations and guidance. Develop and review clinical research protocols, monitoring plans, safety plans, and associated documents. Review investigational brochures, case report forms, and informed consent compliance. Review submissions to the FDA for regulatory compliance and quality. Serve as liaison between satellite trial sites and the sponsor. Educate investigators regarding regulatory requirements. Ensure PV and clinical operations activities comply with GCP, local regulations, and Standard Operating Procedures. Prepare for and manage audits and inspections; implement corrective and preventive actions (CAPAs) and track their effectiveness. Develop and deliver training to internal teams and vendors on safety reporting, GCP, and operational procedures. Requirements Appointment may be subject to a suitability or fitness determination, as determined by a completed background investigation. This position requires submission of a Public Financial Disclosure Report (OGE 278) or a Confidential Financial Disclosure Report (OGE 450) upon entry and annually thereafter. Holder must obtain and maintain a determination of eligibility for a Secret security clearance. Appointment is subject to a one‑year probationary period unless the appointee has previously met the requirements described in 5 CFR Part 315. Temporary Duty (TDY) or business travel of up to 15 % of the time. Qualifications US Citizens may apply. Basic requirement: Bachelor’s or higher degree in a medical, health sciences, or allied sciences field from an accredited U.S. institution. Applicant must meet all basic education requirements and submit transcripts. Specialized Experience One year of experience maintaining regulatory compliance with FDA regulations, GLP requirements, and other relevant regulations. Experience interacting with internal and external stakeholders to ensure regulatory compliance and patient safety. Experience managing safety pharmacovigilance and clinical operations for regulated research trials. Experience developing and reviewing clinical monitoring plans, pharmacovigilance plans, SOPs, and regulatory safety reporting. Education Applicants with foreign education must have credentials evaluated by a private organization and deemed equivalent to an accredited U.S. institution. Additional Information Male applicants born after December 31 1959 must complete a Pre‑Employment Certification Statement for Selective Service Registration. Proof of U.S. citizenship required. Direct deposit of pay is required. Selection is subject to restrictions from the Department of Defense referral system for displaced employees. Recruitment or relocation incentives may be authorized for highly qualified candidates. Multiple positions may be filled from this announcement. Salary includes applicable locality pay or local market supplement. Payment of Permanent Change of Station costs is not authorized. #J-18808-Ljbffr TryApplyNow