The Life Science Career NetworkCTC is a specialized industry expert in sourcing top talent and providing reliable HR and consulting services. We support candidates in finding promising career opportunities and offer cutting-edge skill development training programs.About Our ClientOur client is a global leader in drug discovery and development and a pioneer in personalized healthcare. As the world's largest R&D investor in the pharmaceutical and diagnostics fields, they operate across a wide range of therapeutic areas and are internationally recognized for their innovation and impact.About the RoleWe are seeking a highly motivated Biomarker Clinical Operations Lead (Biomarker Operations Project Manager) to join our client's Pharma Product Development (PD) Global Clinical Operations department in Basel. This is an unlimited contracting position. In this role, you will provide biomarker operational expertise by planning, coordinating, and overseeing all operational activities related to biomarker and companion diagnostic samples and data for PDG clinical studies. This is an exciting opportunity to contribute to cutting-edge drug development and improve patient outcomes through innovative medicines.Responsibilities:
Provide biomarker/IVD operational expertise to clinical study teams, ensuring operational feasibility and quality data delivery.
Develop the Biomarker Management Plan and oversee the execution of deliverables for assigned drug and device studies.
Manage all study-level biomarker operations activities, including vendor and testing site management, protocol input, eTMF/RACT setup, sample/data flow, and quality control.
Partner with internal and external stakeholders for central lab setup, ensuring accurate sample collection, processing, and shipping logistics.
Lead vendor selection and oversight, defining scope of work, budget, quality expectations, and performance management.
Collaborate with Data Management to coordinate biomarker data format and delivery timelines.
Serve as the single point of contact for biomarker/IVD operations across multiple study teams, partnering with biomarker science, CDx, procurement, and other key stakeholders.
Provide technical expertise related to biomarker analyses, including sample handling, assay methodologies, and imaging technologies.
Oversee biomarker analysis timelines, budget, risk, compliance, and quality, ensuring adherence to ICH/GCP, SOPs, ISO 20916, and regulatory requirements.
Conduct training sessions and presentations for internal and external stakeholders on biomarker and companion diagnostic sample collection, handling, and IVD procedures.
Address biomarker sample/IVD-related inquiries from Health Authorities.
Identify best practices and contribute to process improvements within biomarker operations.
Qualifications:Education:
Minimum Bachelor's or Master's degree in Life Sciences (e.g., Scientific, Medical, or Healthcare-related field).
PhD and/or project management certification is desirable.
Experience & Skills:
Minimum of 3+ years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
Extensive experience in clinical development, with a strong background in clinical study operations.
Strong experience with vendor and project management.
In-depth knowledge of the drug development process and regulatory guidelines, including ICH/GCP.
Hands-on experience with biological sample processing and/or laboratory analysis.
Proven ability to work in a global, cross-functional matrix environment.
Excellent communication, collaboration, and influencing skills.
Strong critical reasoning abilities with a detail-oriented and independent work approach.
Fluency in English (additional languages are a plus).
Interested?To learn more about this exciting opportunity, please contact Vanessa Gilardoni at vanessa.gilardoni@ctcresourcing.com or click the 'Apply Now' button.
