Role qualification needed :

1. Minimum 6+ years of Data Management Experience is must.

2. Strong work experience into end-to-end DM role.

3. Should be from Pharma and/or CRO experience.
4. Understanding of disease area.
5. Understanding of laboratory data.

Key Responsibilities (No More than 10 Bullet Points): Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role.

• 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, vendor data, and 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.

• 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 study outsourced through a DM Functional Service Provider (FSP), conducts & documents DM sponsor oversight of the end-to-end FSP study related activities and ensures training on the protocol to the FSP resources working on the study. May oversee Full Service Outsourced (FSO) studies.

• 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.

• 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.

Why GSK?

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

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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