Clinical Trial Operations Manager
1 semana atrás
At Johnson & Johnson, our vision is to make a difference in the lives of people around the world. We are driven by our mission to improve health and well-being through innovation. As a Senior, Site Manager, you will play a key role in delivering this mission by ensuring that clinical trials are conducted efficiently and effectively.
Job Description:A Senior, Site Manager is a mid-level site management role with typically 3-5 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. The Senior, Site Manager will be responsible for ensuring inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure.
- Acts as primary local company contact for assigned sites for specific trials.
- Active participation in site feasibility and/or Site Qualification Visit.
- Attend/participate in investigator meetings as needed, may be expected to help prepare meeting materials and may be required to present at the IM.
The Senior, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. A Senior, Site Manager may contribute to process improvement, training and mentoring of other Site Managers.
Responsibilities:-
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