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Job Location | Cambridgeshire |
Education | Not Mentioned |
Salary | Competitive salary |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent, full-time |
A Genomics/ BioMarker Project Manager required for our client who specialises in providing solutions for life sciences in Biomarkers, Pharmacokinetics, Bioanalysis and Logistics. This specific individual will join their function for the outsourcing of Genetics/Genomics biomarker projects. You will be part of a team that organizes and monitors biomarker studies on behalf of a sponsor conducted at CROs. As a Genomics/ BioMarker Project Manager you will be responsible for:• The organization, coordination and monitoring of genetics/genomics biomarker analysis at CROs in support of development projects.• Data transfer from CROs to internal databases.• Regulatory compliance of all conducted work, including documentation.Key Duties and Responsibilities:• Engage with CROs/Laboratory service organizations to monitor progress and maintain oversight of agreed outsourced bio-analytical activities.• Develop and track RFP/contract documentation both internally to client and externally with selected bio-analytical CROs. • Monitor and respond to correspondence from various internal functional/stakeholder groups involved in clinical sample analysis and data processing. These will include the client CRO facing sample managers, biomarker scientists, data acquisition function, procurement, and sample repository representatives.• Update and maintain activity tracking spreadsheets, including budget planning and forecasting, and vendor oversight documentation.• Ensure all associated clinical study documentation follows regulatory compliance and is made accessible for upload to eTMF.• Uploading and verification of bio-analytical data generated by CROs to client data servers. Key skillset / experience required: • BSc in biology, bioanalysis, genomics or have equivalent industry experience.• Proven experience in clinical development is required. • Prior experience in oversight of external partners, laboratory service providers is desirable.• Genomics and Biological/bioanalytical expertise and experience with databases and project management tools (e.g. SMART sheets) are of benefit.• The role will involve some limited European travel, once or twice per year.