Title: Biomarker Operations Project Manager
Main Responsibilities and Accountabilities:
- Provides biomarker operational expertise and guidance to 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, where applicable.
- Builds and maintains effective and efficient high performing biomarker sample* analysis & data delivery. Supports relevant stakeholders in their accountabilities, responsibilities and deliverables to drive decisions on timelines.
- Responsible for the identification and selection of biomarker vendors in collaboration with the BOPL, biomarker scientist, GPPS and diagnostics/CDx managers; ensuring appropriate cross-functional input is incorporated into the scope of work.
- Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at study level.
Skills & Knowledge: Experience
- Extensive clinical development experience with evidence of working in teams running clinical studies
- Pharmaceutical industry experience or experience working as a clinical trial coordinator within a clinical trial setting is a plus
- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
- Project management skills
- Critical reasoning skills including the identification and resolution of complex problems
- Detail oriented with the ability to work independently and manage multiple competing priorities
- Planning, organizational and time management skills
- Highly flexible in a fast pace global matrix environment
- Professional interpersonal skills, excellent oral/written communication and influencing skills
- Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team
- Creates team culture and promotes team spirit.
- Global Vendor Management experience preferred
- Good knowledge of ICH GCP Competencies
- Strategic Agility
- Inspiring and Influencing
- Teamwork and Collaboration
- Technical and Business Expertise
- Achieving Results
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
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