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ManpowerGroup is the world''s leading workforce solutions provider.
With our three brands Manpower, Experis, and Talent Solutions we support companies from various industries with their recruitment needs. For 75 years, we have been active in over 75 countries, successfully helping our clients across Switzerland achieve their goals and implement their projects.
We are looking for a Biomarker Clinical Operations Lead in PDG (m/f/d) (LSW) BS Metropolitan Area Basel
Responsibilities & Key Tasks:
1. Offer expertise in biomarker and in vitro diagnostic (IVD) operations to clinical study teams, ensuring seamless execution and high quality data collection.
2. Take ownership of the Biomarker Management Plan, overseeing deliverables for assigned pharmaceutical and medical device studies, including IVD clinical performance trials, in close collaboration with the Clinical Study Lead or their delegate.
3. Manage all biomarker related operational activities at the study level, covering both drug and IVD trials. This includes vendor and testing site coordination, protocol and informed consent form (ICF) contributions, setup of eTMF/RACT, and ensuring sle and data flow processes meet quality standards.
4. Work closely with internal and external partners to coordinate central lab setups, including defining sle collection and processing instructions, shipment logistics, and overall biomarker sle management.
5. Take the lead in identifying, selecting, and managing biomarker vendors, negotiating scope of work and budgets while ensuring adherence to quality expectations and performance metrics.
6. Partner with Data Management teams to align biomarker data formats with study requirements and ensure timely data delivery.
7. Collaborate with cross functional stakeholdersincluding clinical study teams, biomarker scientists, companion diagnostics (CDx) specialists, procurement teams, and lab/diagnostic partnersto implement biomarker and IVD strategies. Serve as the primary liaison for biomarker operations across multiple studies.
8. Apply technical expertise related to biomarker analysis, covering aspects such as sle handling, assay/device selection, and imaging technologies.
9. Monitor and manage timelines, budgets, risk factors, regulatory compliance, and quality for biomarker related activities, ensuring adherence to ICH/GCP, SOPs, ISO 20916, and regulatory guidelines.
10. Participate in operational and investigator meetings, providing in depth training and presentations on biomarker sle collection, handling, and IVD procedures to internal and external teams.
11. Address queries from healt