Trial Master File/eTMF Associate
Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Trial Master File/eTMF Associate to be located in Somerville, NJ; Irvine, CA; Cincinnati, OH; Warsaw, IN; West Chester, PA; Raynham, MA; Leeds, UK, Diegem, Belgium.
Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.
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On behalf of the Medical Device Clinical R&D COE, the TMF/eTMF Associate will be responsible for the management of Trial Master Files (paper and electronic) in North America and the work performed by the clinical study administration in the region. This individual will be responsible for contractors, and functional sources training and performance and assisting the TMF/eTMF Leader-Global with contracting of these resources. The TMF/eTMF Associate will:
- Ensure efficient use of Clinical Study administration resources (contractors, functional resources) to provide quality deliverables while maintaining optimal efficiency and cost effectiveness for all assigned clinical operations activities across all franchises.
- Ensure personal and company compliance with all Federal, State, local, and company regulations, policies and procedures for Health, Safety, and Environmental compliance.
- Assist the TMF/eTMF Leader with defining and administering budgets for contract and functional sourced clinical study administration services.
- Support the TMF/eTMF Leader to assure strategies, resources, and accountabilities are in place to achieve rapid, cost-effective, and well-executed clinical studies in assigned territories in collaboration with regional CTMs and CTLs.
- Participate in project management meetings and provide an overview of TMF status, clinical study administration resources quality and workload on a regular basis.
- Communicate effectively with clinical study administration vendors (Functional Service providers etc.).
- Assist in the tracking of all start-up activities (site and country study submissions and essential documents status).
- Collaborate with internal partners and support implementation and on-going use of CTMS and eTMF and any additional new platforms in the future within the Clinical COE, acting as a Subject Matter Expert for Clinical R&D Operations.
- Provide input to the TMF/eTMF Leader - Global in regard to potential opportunities for optimization of such systems and platforms.
- Participate in Clinical Study Core team meetings, as required, and provide an overview of clinical study administration resource staff quality and workload.
- Provide internal communication of important clinical data and events and establish themselves as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key stakeholders.
- Participate in departmental initiatives aimed at improving process and efficiency, in particular for the development and optimization of global processes to the overall benefit of the Clinical R&D Operations CoE.
- Ensure sponsor file readiness of allocated studies/TMFs at all times for inspection by health authorities (including FDA BIMO inspections) and work in collaboration with the TMF/eTMF Leader to ensure file readiness and provide technical support in preparation for site and incoming (including internal) audits. S/he may be involved in other tasks to support Clinical R&D Operations and Franchise Clinical R&D, as needed.
- A minimum of a Bachelor's degree (or University equivalent) is required
- A minimum of 4 years of clinical research experience is required
- Understanding and working knowledge of regulations and standards applied in clinical areas, medical devices and/or pharmaceutical products is required
- A minimum of 2 years of TMF documentation experience is required
- Previous supervisory or mentoring experience is preferred
- Clinical/medical background is preferred
- Experience providing oversight and guidance for multiple projects and focus areas simultaneously is preferred
- Position to be located in Somerville, NJ; Irivine, CA; Cincinnati, OH; Warsaw, IN; West Chester, PA; Raynham, MA; Leeds, UK; Diegem, Belgium and will require up to 10% travel
United States-New Jersey-Somerville
North America-United States-Indiana-Warsaw, Europe/Middle East/Africa-United Kingdom-England-Leeds, North America-United States-Pennsylvania-West Chester, North America-United States-California-Irvine, North America-United States-Massachusetts-Raynham, North America-United States-Ohio-Cincinnati, Europe/Middle East/Africa-Belgium-Brussels-Capital Region-Diegem
Depuy Orthopaedics. Inc. (6029)
Clinical Trial Administration
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