# Clinical Data Management

**Company**: GSK
**Location**: Warsaw
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: PLN 255,750 to PLN 426,250
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Warsaw/Manager--Data-Management_451156-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/clinical-data-management-4704da58-703/

## Description

Clinical Data Management is responsible for overseeing the end to end DS&M study related activities and is accountable for all DS&M study deliverables in terms of quality & delivery to plan.

Key Responsibilities:

- Accountable for the end to end DS&M study related activities in terms of quality & delivery to plan

- Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation

- Interim and final cleaned database lock

- Archival of all DM documents in the eTMF

- 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

- 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

- 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

- 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

- 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

Basic Qualification:

- Bachelor’s degree in a scientific, clinical, computer, or related discipline

- Minimum of 4 years’ experience in data management or clinical trials within pharmaceutical, contract research organization (CRO), or academic research settings

- Practical knowledge of Good Clinical Practice and regulatory requirements for clinical data management

- Experience managing relationships and oversight with external vendors or service providers

- Strong English communication skills, both written and verbal, for effective global collaboration

- Proven ability to plan and deliver study-level activities and timelines

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## Skills

### Required
- Clinical Data Management
- Good Clinical Practice
- Data Management
- English

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