Clinical Biomarker (Biosample) Operations Project Manager
Our client is a pioneer in Drug Discovery and Development. As the world`s largest R&D spender in the pharmaceutical domain, they work in a vast number of drugs & therapeutic areas and are highly recognized internationally. They are also a leader in the field of manufacturing and selling of several drugs for the treatment of Cancer.
They are currently looking for a Biomarker Operations Project Manager for a 12 months contract with high chances of extension, to be based in Basel. If you have 3+ years of experience clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment with planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker/biosamples and experience with evidence of working in teams running clinical studies , this is the right opportunity for you!
Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies within the Oncology Therapeutic Area through all phases (phase Ib-IV) .
- Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies within the Oncology Therapeutic Area through all phases (phase 1b-IV) supported by Pharma Development
- Provides biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs)
- Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples, collection, processing, analysis, data delivery process and final sample disposition).
- Responsible for collaborating closely with biomarker scientists and Biomarker Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders.
- Develops and maintains effective working relationships with SMT members, with particular focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors
- Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans
- Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
- Delivers the operational elements of the biomarker management plan
- Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
- Identifies areas of best practice and process improvements; may lead or be a representative on functional groups goals, initiatives and work-streams
- Ensures study and biomarker operational adherence to ICH/GCP and SOPs
Qualifications and Experience:
- Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable.
- 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
- Extensive clinical development experience with evidence of working in teams running clinical studies
- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
- Project management skills and global Vendor Management experience preferred
- Critical reasoning skills including the identification and resolution of complex problems
- Fluency in written and spoken English.