Senior Clinical Research Manager - (US-NJ-Morristown - 07963)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Ensures quality and timely completion of deliverables.2. Trouble-shoots and facilitates resolution of clinical study issues.3. Resolves site recruitment issues to facilitate on schedule completion of investigator sponsored trials.4. Leads in the evaluation, selection, contracting, and management of investigative sites, central laboratories, and central Leads the negotiation of contracts with central laboratories, central expert consultants, and vendors.6. Leads the preparation and review of clinical documentation required for annual reports and the submission of INDs and NDAs according to GCP.7. Supervises activities of internal and external data management resources.8. Participates in the design and evaluation of CDPs for new drugs, reformulations, and prescription-to-OTC switches.9. Trains consultant CRAs.10. Reviews scientific sections of reports including INDs and NDAs and study summaries for periodic or annual reports to the FDA. Also reviews scientific data from other departments (e.g., formulation development, analytical development) on a per-project basis.11. Contributes to the global standardization and improvement of clinical operations processes and procedures by evaluating, revising or creating, and implementing procedures to streamline departmental processes.12. Reviews study timelines including target milestone dates in order to track progress against a predefined project plan.

Requirements :The position requires an advanced degree (M.S., M.P.H, Pharm.D., Ph.D.) as well as experience in pharmaceutical research, specifically exposure to the IND/NDA approval process and Phase I, II, III and IV clinical research. The incumbent should have at least 8 years (Masters degree) or 6 years (Doctoral degree) of directly related pharmaceutical clinical research and clinical trial management experience.  CCRA Certification is strongly preferred.  The position requires research administration experience, practical experience in leading multidisciplinary teams, knowledge of scientific principles of controlled trials, past experience in facilitating the timely execution of CDPs, thorough knowledge of study monitoring procedures, and a comprehensive knowledge of FDA and ICH guidelines.

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