Site Name: Bengaluru Luxor North Tower

Posted Date: Apr 16 2026

Job Description

Key Responsibilities:

Accountable for the end-to-end DS&M study related activities in terms of quality & delivery to plan which include:
o Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments
o Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation
o Interim and final cleaned database lock
o Archival of all DM documents in the eTMF
o 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, new/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 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

Minimum Level Of Education Required

Bachelor's Degree, in scientific or business discipline

Area of Specialization

Clinical trial experience.
Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP).
Understanding of the tools of the trade, such as standards

Job-Related Experience Required

Pharma and/or CRO experience.
Understanding of disease area.
Understanding of laboratory data.
Understanding of applicable ICH/GCP regulations and applicable GSK policies and SOPs
Experience working with global suppliers/ partnerships to ensure deliverables are to the agreed standard
Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets
Operates across a global, complex organization. Includes applying the processes, methods, tools and approaches used to facilitate data management activities, and the day-to-day running of a project or study-aligned team
Supports capability build across the function
Develops recommendations for study or project issue resolution
Builds influential networks within the organization & study team members. Uses these relationships to generate buy-in and support for the project, Data Management Plan or equivalent, to ensure mutually advantageous resources and goals
Ensure sharing of knowledge and learning with the GSK Data Management Community
Assists in operational excellence and data quality focus negotiations with vendors and strategic partners
Communicates technical topics to a non-technical audience.
Uses an extensive network within GSK and external to keep abreast of industry trends and be part of the development of those trends
Certification: CCDM (if present) added advantage.

Why GSK

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

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