Onsite Data Lead – Clinical Data Manager

Posted 1 hour ago

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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

Job title

Data Lead – Clinical Data Manager

Job type

Experience level

Senior

Salary

CA$112,000 - CA$162,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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