Biomarker Clinical Operations Lead in PDG (m/f/d)

We are looking for a motivated and committed Biomarker Clinical Operations Lead in PDG for our client, F. Hoffmann-La Roche Ltd. based in Basel, for a 12 month assignment with the option to extend.

The Biomarker Clinical Operations Lead (Biomarker Operations Project Manager accountable) in PDG at Roche/Genentech is responsible and accountable to provide BIOMARKER OPERATIONAL EXPERTISE by planning, coordinating, and overseeing all operational activities for the lifecycle of biomarker and companion diagnostic samples and data, for PDG clinical studies.

Tasks

• Biomarker Operations Management: Oversee the planning, execution, and quality assurance of biomarker and IVD studies, including the development of the Biomarker Management Plan
• Stakeholder & Vendor Management: Collaborate with internal and external partners (e.g., central labs, testing sites, diagnostic partners) and manage biomarker vendors to ensure quality and performance
• Data & Sample Management: Organize biomarker sample flow (collection, logistics, processing) and coordinate with data management to ensure data quality and timely delivery
• Regulatory & Compliance Oversight: Ensure adherence to ICH/GCP, ISO 20916, and other regulatory requirements while supporting responses to health authority inquiries
• Process Optimization & Training: Identify best practices, contribute to process improvements, and train internal and external stakeholders on biomarker and IVD procedures

Must Haves

• Bachelor's or Master's degree in Life Sciences, preferably with additional qualifications (PhD or project management certification)
• Minimum of 3 years of experience in clinical research, pharmaceutical development, or diagnostic laboratories
• Strong expertise in clinical development, project and vendor management, and regulatory requirements (ICH/GCP)
• Excellent analytical, organizational, and communication skills, with the ability to manage multiple priorities
• Fluent in English; additional language skills are a plus

Have we sparked your interest?

Don't hesitate and submit your complete application documents online today.

We look forward to hearing from you!

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Kontakt
Laura Bermejo Martin

Arbeitsort
Basel

Pensum
100%

Position
Mitarbeiter

Branche
Pharma + Chemie + Life Science