Senior Clinical Data Manager (Bengaluru)

Senior Clinical Data Manager (Bengaluru)

13 Aug
|
Fortrea
|
Bengaluru

13 Aug

Fortrea

Bengaluru

Job Overview
Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Assume responsibility for all DM activities (from study start-up to database lock) according to client quality expectations, within project timelines and budgets. Act as subject matter expert (SME) for DM activities in relationship meetings with Sponsors. Work directly with Sponsors to understand their direct requirements and lead implementation of those requirements. Regularly review client specific process to ensure they remain optimal for Sponsor and Fortrea. The Senior Clinical Data Manager will work with the leadership team to provide guidance, mentoring and training to DM to ensure best working practices are maintained.

Summary Of Responsibilities
- Develop the Vendor Data Plan (VDP), including the Data Quality Review reconciliation section, or sponsor equivalent, for the external vendor data transfer(s),



obtain final approvals and file document to the Trial Master File (TMF) as applicable. May participate in review of external vendor Statement of Work (SOW) for study scope, and ensure all protocol specified parameters are present as applicable.
- Ensure electronic external vendor data transfers contain all protocol specified parameters, is in correct format, and data populates to the specified fields and subjects correctly as designated in the Vendor Data Plan (VDP) or sponsor equivalent.
- Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, robust client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables.
- As the Study Manager, be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study tea

📌 Senior Clinical Data Manager (Bengaluru)
🏢 Fortrea
📍 Bengaluru

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