GSK is a global biopharma company dedicated to uniting science, technology, and talent to advance health. The Clinical Data Manager will oversee end-to-end data management study activities, ensuring quality and compliance while leading operational aspects of clinical studies.
For an in-house study, leads the day-to-day DS&M operational study related activities, acts as a member of the study 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 and escalates as required to DM representative at Asset level
Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines
Qualification
Required
Bachelor's degree from Scientific Discipline (Biomedical or Computer)
1 to 3 years' experience of data management/clinical trials experience in Pharma, CRO and/or ARO
Two or more years of experience with general data flow & database architecture concepts
Two or more years of experience with clinical drug development process and regulations including ICH-GCP, 21 CRF part 11, CDISC requirement
Two or more years of experience working with industry principles of quality, safety, risk management and compliance (ICH and GCP)
Preferred
Excellent interpersonal and teamwork skills
Demonstrates adaptability and an agile mindset
Result-driven, proactive, detail-oriented, problem solver
Willing to work in a Global environment
Fluent in written and spoken English
Proven ability to prioritize and multi-task, along with effective time management skills
Benefits
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://GSK.to/socialmedia
