GSK
biopharma
Manager,ClinicalDataManager
“Manager, Clinical Data Manager at GSK. Skills: Clinical Data Management, Data Management, Data Validation. Accountable for end-to-end DS&M study activities. Define and execute Data Management Strategy”
What You'll Achieve.
Accountable for end-to-end DS&M study related activities in terms of quality & delivery to plan
Industry & Context.
Risk Management; Mediates and solves issues related to DM study deliverables
What They're Looking For.
Must Have
Clinical Data Management, Clinical Development, Clinical Information Systems, Clinical Trial Designs, Data Management, Data Validation, Risk Management, Data Analysis
What You'll Do.
Accountable for end-to-end DS&M study activities
Define and execute Data Management Strategy
Manage interim and final cleaned database lock
Archive DM documents in eTMF
Archive study database
Provide clinical data to study site
Manage complex studies
Lead day-to-day DS&M operational activities
Act as member of study core team
Single point of contact for DM study activities
Conduct sponsor oversight of FSP/FSO activities
Ensure training on protocol to FSP resources
Provide DM operational input into study design
Provide reports and status updates
Oversee and provide input to budgets
Create or review study level timelines
Promote implementation of clinical data standards
Act as first point of escalation for DM study issues
Ensure DM study deliverables compliance
Develop and maintain professional relationships
Act as mentor for junior DS&M team members
Act as Subject Matter Expert for new processes
Support implementation of data standards
Support implementation of new systems
Support vendor quality assessments
Support audits and inspections
How You'll Work.
Team & Collaboration
Act as member of the study core team; Develop and maintain excellent professional relationships with study team; Act as mentor for junior members of the DS&M team
Communication Scope
Communication; Influencing Without Authority; Stakeholder Management
Process & Methodology
Manage complex studies, Create or review study level timelines, Ensures teams adhere to timelines
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