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Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Mumbai, India

Job Description:

A Senior, Local Trial Manager is a mid-level trial management role with typically at least 2 years of clinical trial management or atleast 6-8 years of clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Senior, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The Senior, Local Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Senior, Local Trial Manager actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and Associate, Local Trial Managers. The Senior, Local Trial Manager may have some site management responsibilities.

Configures systems to facilitate the operations of clinical trial phases to ensure staff are able to complete testing and analysis in a timely and effective manner.
Analyzes standard operating procedures for clinical trial project management to ensure current methods are optimized and determine methods of improvement. Documents findings and events throughout the duration of a clinical trial project to present findings to leadership and ascertain organizational trends. Incorporates relevant modern advances in the field into clinical research to ensure the company stays up-to-date on the current knowledge and practices of the field. Edits and writes draft presentations and manuscripts for clients and stakeholders. Communicates with stakeholders and site staff on relevant discoveries or issues to ensure all involved parties are informed of project affairs. 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 Local Trial Manager