Biomarker Clinical Operations Lead in PDG (m/f/d)
Biomarker Clinical Operations Lead in PDG (m/f/d)
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Work Selection AG
We are proud to be a first-tier supplier to Roche. For our valued partner, F. Hoffmann-La Roche Ltd. based in Basel, we are currently seeking a motivated Biomarker Clinical Operations Lead in PDG for a temporary position of one year with the possibility of extension.
This position 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
What We Offer
* Flexible remote work options
* Competitive salary
* Access to ongoing training and professional development
* A dynamic and supportive team environment
* Opportunities for significant impact and contribution to key projects
Have we sparked your interest?
Don't hesitate and submit your complete application documents online today.
We look forward to hearing from you!
Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen ? unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.
Temporär
100%
Mitarbeiter
Settore: Altro
Ruolo: Altro
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Temporary
Job function
* Job function
Management and Manufacturing
* Industries
Manufacturing
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