Manager Data Management position at GSK overseeing end-to-end study activities and data management strategies. Lead efforts towards data quality, compliance, and operational excellence across clinical trials.
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
For an in-house study, leads the day to day DS&M operational study related activities
Conducts & documents sponsor oversight of the end to end FSP/FSO study related activities
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
Requirements
Bachelor’s Degree, in scientific or business discipline
Clinical trial experience
Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP)
Understanding of the tools of the trade, such as standards
Pharma and/or CRO experience
Understanding of disease area
Understanding of laboratory data
Understanding of applicable ICH/GCP regulations and applicable GSK policies and SOPs
Experience working with global suppliers/ partnerships to ensure deliverables are to the agreed standard
Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets
Operates across a global, complex organization
Supports capability build across the function
Builds influential networks within the organization & study team members
Communicates technical topics to a non-technical audience.
Benefits
private healthcare
additional paid days off
life insurance
private pension plan
fully paid parental leave & care of family member leave
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