Job Summary

The role is accountable for end-to-end Data Management study delivery, ensuring high-quality clinical data and on-time execution across in-house and outsourced studies. This includes ownership of electronic case report forms and clinical outcome assessments, defining and executing the data management strategy (ingestion, cleaning, reconciliation), managing interim and final database locks, and overseeing archival of DM documentation and study databases. The position leads day-to-day DS&M; operations for in-house studies as the single point of contact and provides robust sponsor oversight for FSP/FSO studies, including protocol training for vendor resources.

Location

This role is based in India and follows a hybrid working model with agreed on-site days as discussed with your line manager.

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 oversee and provide 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 escalates as required to DM representative at Asset level.





- Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines.

- Develops and maintains excellent professional relationships with study team and other key stakeholders

- Acts as a mentor for junior members of the DS&M; team.

- Acts as a Subject Matter Expert supporting the implementation of new processes, data standards, trainings, systems, vendor quality assessments, audits and inspections.

Requirements

We are seeking professionals with the following skills and qualifications to help us achieve our goals:

- Bachelor's degree in life sciences, computer science, engineering, statistics, or a related discipline.

- Minimum 10 years of hands-on experience in clinical data management, or similar roles in pharmaceutical, biotech or CRO settings.

- Practical experience building and validating electronic data capture systems and study databases like

- Proven experience managing study timelines, stakeholder communication and vendor oversight.

- Strong written and verbal English communication skills and ability to produce clear study documentation.

- Basic knowledge of data integration or scripting (e.g., SQL, Python) for finance reporting.

Skills

- Clinical Data Management

- Electronic Data Capture

- Data Management

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Manager - Data Management (Bengaluru)
🏢 GSK India
📍 Bengaluru