Technical Lead governing AI data readiness and API gateways at Coupa, whose platform helps businesses optimize total spend. Defining safeguards for GenAI applications, data quality, compliance, and observability.
About the role
- Clinical Data Manager responsible for overseeing end-to-end data management study activities at GSK. Ensuring quality and compliance in key deliverables for clinical trials.
Responsibilities
- Overseeing the end-to-end DM study related activities
- Accountable for all Data Strategy & Management (DS&M) study deliverables
- Act as a member of the study team and is the single point of contact for all the DM study related activities & matters
- Conduct & document DM sponsor oversight of the end-to-end FSP study related activities
- Provide DM operational input into the study design, protocol, planning, and study documents
- Ensure DM study deliverables are in compliance with GSK SOPs and regulatory guidelines
Requirements
- 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).
Benefits
- Health insurance
- Professional development opportunities
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