Role OverviewPlay a key role in the communication and integration of translational medicine objectives with clinical study team members during protocol development and execution. Serve as a member of the Translational Medicine clinical study start team; support the tactical execution of biospecimen collection and analysis during clinical protocol development, study start-up and amendments.
What You Will Do
Contribute to activities involving the Data Management team, including eCRF set-up, database build for sites and sample tracking/reconciliation. Participate in efforts to standardize nomenclature, pictograms, sample handling instructions, and resources for all central labs to ensure consistency across studies.
Why It Might Be a Fit
Must be able to prioritize workload in response to the specific needs of numerous protocols and department. Maintain awareness of local and international regulations as pertains to protecting the privacy of personal information that may be associated with clinical samples.
Requirements
- Scientific background (BS, RN, Med Tech)
- Minimum of 2 years’ experience in clinical drug development, clinical trial execution, central lab study setup with exposure to biomarkers, pharmacokinetics or immunogenicity sample activities
- Experience working with Contract Research Organizations (CRO)
- Demonstrated knowledge of ICH and GCP
- Advanced skills in Microsoft Office programs
- Good working knowledge of electronic data systems and controlled sample management systems
- Detailed and precise record keeping skills
- Ability to track and resolve issues
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities
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