GSK

Healthcare

DataLead

$172–286k warsaw, mazovia, 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, Study oversight. Lead end-to-end DS&M study activities. Define Data Management Strategy”

What You'll Achieve.

Quality & delivery to plan; Increase consistency; Increase efficiency; Increase productivity

Industry & Context.

Healthcare
Problems you'll solve

Practical problem solving; Mediate and solve issues

What They're Looking For.

Must Have

Clinical Data Management processes, Clinical data management standards, Clinical systems, Microsoft Excel, Validation methodology, General data flow concepts, Database architecture concepts, ICH-GCP, 21 CRF part 11, CDISC requirement, Clinical drug development process, Vaccine development process

Nice to Have

InForm, Rave/ Veeva/ OC, e-Diaries, e-Source, PL SQL, SAS

What You'll Do.

Lead end-to-end DS&M study activities

Define Data Management Strategy

Execute data cleaning

Execute data reconciliation

Perform database lock

Provide clinical data

Lead DS&M operational activities

Act as member of study core team

Conduct DM sponsor oversight

Provide DM operational input

Create study timelines

Promote clinical data standards

Act as first point of escalation

How You'll Work.

Team & Collaboration

Work closely with internal study teams; Work closely with external vendors; Work closely with technical partners; Act as member of the study core team; Liaise with key study stakeholders; Develop professional relationships with study team; Develop professional relationships with key stakeholders

Communication Scope

Clear communication

Process & Methodology

Study planning, Study timelines

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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