Clinical Trial and Pharmacovigilance Operations Manager

About the role

About the Position: MRDC is now part of the Defense Health Agency (DHA) Research & Development (R&D). We are the medical materiel developer, with responsibility for medical research, development and acquisition. Our expertise in these critical areas helps establish and maintain the capabilities the military needs to remain ready and lethal on the battlefield. Please visit our website https://mrdc.health.mil/ This is a Direct Hire Solicitation Who May Apply: US Citizens DHA Research & Development (R&D) is participating in an alternative personnel system known as thePersonnel Demonstration Project (PDP). The DB-03 payband is equivalent to the GS-13 step 1 to GS-14 step 10 level. In keeping with the Demonstration pay fixing policies, employees earning a salary that fallswithin this payband equivalent, may not receive an immediate pay increase (promotion) if appointed tothis position. Future pay increases within the payband will be accomplished through the pay forperformance management system. In order to qualify, you must meet the education and experience requirements described below. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is in this document. Basic Requirement for Clinical Trial and Pharmacovigilance Operations Manager: Degree: Bachelor's or graduate (or higher level) degree with major study in an academic field related to the medical field, health sciences, or allied sciences appropriate to the work of the position. This degree must be from an educational program accredited by an accrediting body recognized by the U.S.Department of Education at the time the degree was obtained. You MUST submit copies of your transcripts supporting your education. In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below: Specialized Experience: One year of specialized experience which includes: 1. Experience maintaining regulatory compliance in accordance with Food and Drug Administration (FDA) regulations, and Good Laboratory Practice (GLP) regulatory requirements. 2. Experience interacting with team members, varied groups, and/or types of internal and external stakeholders to ensure regulatory compliance and patient safety in clinical research. 3. Experience managing safety pharmacovigilance and clinical operations for regulated research trials 4. Experience developing and reviewing clinical monitoring plans, pharmacovigilance plans, clinical standard operating procedures, and/or regulatory safety reporting This definition of specialized experience is typical of work performed at the next lower grade/level positionin the federal service (DB-02 / GS-12).

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