Data Scientist developing AI agents and advanced analytics solutions for Ciena. Focused on machine learning, generative AI, and delivering business value through intelligent data - driven tools.
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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