Key Responsibilities:
- Accountable for the end-to-end DS&M; study related activities in terms of quality & delivery to plan which include:
- Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments.
- Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation.
- Interim and final cleaned database lock.
- Archival of all DM documents in the eTMF.
- Archival of the study database and provision of clinical data to the study site.
- Accountable for one or several complex studies and has the ability and experience to manage the delivery of any type of study (different therapeutic areas, complex/unusual early phase setting, current/unusual indication, pivotal/Phase III and efficacy studies, clinical as well as epidemiology studies).
- For an in-house study, leads the day-to-day DS&M; operational study related activities, acts as a member of the study core team and is the single point of contact for all the DM study related activities & matters.




- For a study outsourced through a DM Functional Service Provider (FSP) or Full Services Outsourcing (FSO), conducts & documents sponsor oversight of the end-to-end FSP/FSO study related activities and ensures training on the protocol to the FSP resources working on the study
- Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register.
- Provides reports, status updates, feedback and advice to key study stakeholders on study progress.
- May oversees and provides input to the development of budgets forecasts for FSP and FSO contracts.
- Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these.
- Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity.
- Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escala

📌 Manager, Data Management (Bengaluru)
🏢 GSK
📍 Bengaluru