GSK

Healthcare

DataLead

$240–360k ~AI est. Warsaw, Poland FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Lead candidates.

The Brief

“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.

Healthcare
Problems you'll solve

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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