Description
MANPOWER AG – Your Career, Our Focus!
Become part of our network and take advantage of countless opportunities!
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:
- Offer expertise in biomarker and in-vitro diagnostic (IVD) operations to clinical study teams, ensuring seamless execution and high-quality data collection.
- 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.
- 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 sample and data flow processes meet quality standards.
- Work closely with internal and external partners to coordinate central lab setups, including defining sample collection and processing instructions, shipment logistics, and overall biomarker sample management.
- 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.
- Partner with Data Management teams to align biomarker data formats with study requirements and ensure timely data delivery.
- Collaborate with cross-functional stakeholders—including clinical study teams, biomarker scientists, companion diagnostics (CDx) specialists, procurement teams, and lab/diagnostic partners—to implement biomarker and IVD strategies. Serve as the primary liaison for biomarker operations across multiple studies.
- Apply technical expertise related to biomarker analysis, covering aspects such as sample handling, assay/device selection, and imaging technologies.
- 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.
- Participate in operational and investigator meetings, providing in-depth training and presentations on biomarker sample collection, handling, and IVD procedures to internal and external teams.
- Address queries from health authorities related to biomarker samples and IVD processes.
- Contribute to continuous process improvements and best practice identification, leading initiatives where applicable.
- Execute business priorities as assigned.
- Onsite presence is required as per local regulations.
Required Qualifications:
- Bachelor’s or Master’s degree in Life Sciences (e.g., Scientific, Medical, or Healthcare disciplines). A PhD or project management certification is a plus.
- At least three years of experience in clinical research, diagnostics, laboratory operations, or pharmaceutical/biotechnology R&D.
- Extensive background in clinical trial execution, with proven experience in managing study teams.
- Strong expertise in vendor and project management within a clinical research environment.
- In-depth knowledge of the drug development process and regulatory standards, including ICH and GCP guidelines.
- Hands-on experience with biological sample collection, processing, and analysis in a clinical or laboratory setting.
- Ability to work effectively in a global, matrixed environment with cross-functional teams.
- Strong communication, collaboration, and presentation skills, with the ability to influence stakeholders.
- Analytical mindset with problem-solving abilities and a keen attention to detail.
- Capable of working independently while managing multiple priorities.
- Fluency in English is required; additional language skills are advantageous.