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Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

Mumbai, India, PENJERLA, Telangana, India

Job Description:

A Senior, Site Manager is a mid-level site management role with typically 3-5 years of clinical monitoring experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. A Senior, Site Manager is assigned to trial sites to ensure 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. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. 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. A Senior, Site Manager is generally expected to be able to operate independently with little or limited supervision.

Assists throughout the start-up, execution, and completion of clinical research studies, ensuring the safety and confidentiality of all study subjects.
Documents site visits, investigational product assessments, and other relevant observations and identifies opportunities to improve outcomes. Acts as a point of contact for the clinical trial team and escalates issues to appropriate trial leaders. Gathers data on the clinical trial environment and measures against key performance indicators. Observes and trains patients on trial purpose and outcomes in accordance within all regulatory requirements, under general supervision. Maintains records and documentation of safety related events. Coaches more junior colleagues in techniques, processes, and responsibilities. Understands and applies Johnson & Johnson s Credo and Leadership Imperatives in day-to-day interactions with team.

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Senior Site Manager