Role OverviewThe primary responsibility of this role is to provide biomarker technical expertise and support to the Translational Science Lead (TSL) to ensure operational implementation and execution of translational science strategies in clinical trials which may include phase I, II and III studies. The BTE will interface with the TSL and multiple functions throughout the company as well as external partners to support and facilitate biomarker activities including clinical trial start up, sample logistics, lab vendor management (including companion diagnostics partners), data management related support for data collection, transfer, reconciliation and reporting, document preparation, budget support, and more.
What You Will Do
Collaborate closely with TSL, Clinical Operations, Biostatistics/Bioinformatics, and data management teams to support and execute translational science strategies in clinical trials; Develop and provide operational input into all study related documentation and processes, and ensure collection, delivery and analysis of biomarker samples in compliance with these documents as well as GCP/ICH; Serve as a single point of contact for biomarker operations across functions, and with collaborators and CROs.
Why It Might Be a Fit
Bayer seeks an incumbent who possesses the following: Required Qualifications: Bachelor's degree; Extensive pharmaceutical industry experience and in-depth knowledge of clinical drug development; Clinical laboratory experience including involvement in the processing and/or analysis of clinical samples; Project management skills including planning, organizational and time management skills; Global vendor management experience; Critical reasoning skills including identification and resolution of complex problems; Detail oriented with the ability to work independently and manage multiple competing priorities; Proven project leadership skills, ability to successfully achieve results within multi-cultural and geographically diverse teams; Excellent oral/written communication skills.
Requirements
- Bachelor's degree
- Extensive pharmaceutical industry experience and in-depth knowledge of clinical drug development
- Clinical laboratory experience including involvement in the processing and/or analysis of clinical samples
- Project management skills including planning, organizational and time management skills
- Global vendor management experience
- Critical reasoning skills including identification and resolution of complex problems
- Detail oriented with the ability to work independently and manage multiple competing priorities
- Proven project leadership skills, ability to successfully achieve results within multi-cultural and geographically diverse teams
- Excellent oral/written communication skills
Benefits
- health care
- vision
- dental
- retirement
- PTO
- sick leave
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