GSK
Healthcare
DataLead
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“Data Lead at GSK. Skills: Clinical Data Management, Data Management Strategy, DM sponsor oversight. Accountable for end-to-end DS&M study related activities. Define Data Management Strategy”
What You'll Achieve.
Quality & delivery to plan
Industry & Context.
Practical problem solving
What They're Looking For.
Must Have
Experienced in Clinical Data Management processes, Experienced in clinical standards, Experienced in clinical systems, Proficient in Microsoft Excel, Proficient in validation methodology, Understanding of general data flow, Understanding of database architecture concepts, Good understanding of ICH-GCP, Good understanding of 21 CRF part 11, Good understanding of CDISC requirement, Comprehensive understanding of clinical drug development process, Comprehensive understanding of Vaccine development process
Nice to Have
Exposure to InForm, Exposure to Rave/ Veeva/ OC, Exposure to e-Diaries, Exposure to e-Source, Basic knowledge of PL SQL, SAS is an added advantage
What You'll Do.
Accountable for end-to-end DS&M study related activities
Define Data Management Strategy
Execute Data Management Strategy
Perform interim cleaned database lock
Perform final cleaned database lock
Archive DM documents in eTMF
Archive study database
Provide clinical data to study site
Lead DS&M operational study related activities
Act as member of study core team
Act as single point of contact for DM
Conduct DM sponsor oversight of FSP study activities
Document DM sponsor oversight of FSP study activities
Ensure training on protocol to FSP resources
Oversee Full Service Outsourced (FSO) studies
Provide DM operational input into study design
Provide DM operational input into protocol
Provide DM operational input into study planning
Provide DM operational input into study documents
Provide reports on study progress
Provide status updates on study progress
Provide feedback on study progress
Provide advice on study progress
Create study level timelines for DM deliverables
Review study level timelines for DM deliverables
Ensure teams adhere to timelines
Promote implementation of clinical data standards
Act as first point of escalation for DM
Understand issues related to DM study deliverables
Mediate issues related to DM study deliverables
Solve issues related to DM study deliverables
Escalate issues to DM representative at Asset level
Ensure DM study deliverables comply with GSK SOPs
Ensure DM study deliverables comply with regulatory guidelines
Develop professional relationships with study team
Develop professional relationships with key stakeholders
Maintain professional relationships with study team
Maintain professional relationships with key stakeholders
How You'll Work.
Team & Collaboration
Work with internal study teams; Work with external vendors; Work with technical partners; Work with study core team; Work with key stakeholders
Communication Scope
Status updates; Feedback; Advice
Process & Methodology
Timeline management
Full Job Description
You will lead end-to-end clinical data management for a portfolio of studies. You will work closely with internal study teams, external vendors and technical partners. We value clear communication, practical problem solving and a collaborative mindset. This role offers visible impact, chances to grow your skills and the opportunity to help GSK unite science, technology and talent to get ahead of disease together. **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, 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 a
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