The BOS Manager leads end-to-end biomarker operations across Phase I-IV clinical trials, ensuring compliant, high-quality delivery of biomarker samples, data, and vendor activities for complex multi-region studies. This role coordinates cross-functional teams, oversees HGR submissions and regulatory risk, manages timelines and costs, and drives operational excellence to support study milestones and program objectives.
Requirements
- Bachelor's degree or higher in Clinical Medicine, Pharmacy, Nurse, Life Sciences, or related fields.
- GCP certificate is preferred
- CET-4
- At least 3 years of experience in clinical operations or central laboratory operations, including clinical sample tracking/management (e.g., biomarker, PK/PD samples), sample reconciliation, and/or HGR management.
- Solid understanding of analytical methods used in oncology studies.
- Demonstrated experience contributing independently to global (regional) clinical studies, gained through roles in CROs, biotech/pharmaceutical companies, and/or central laboratories.
- Strong written and verbal communication skills, with good English proficiency for working with global and cross-functional teams.
- Experience in project or operational management, preferably in biomarker, translational medicine, diagnostics, or clinical laboratory settings.
- Proficient in standard office tools (Word, Excel, PowerPoint) and basic project-tracking tools.
- Able to take ownership of biomarker operational activities, including planning, coordination, and execution.
- Comfortable working in a fast-paced environment and managing tasks under pressure.
- Experience working in matrix teams, coordinating with Clinical Operations, Translational Medicine, vendors/CROs, and central laboratories.
- Some experience in coordinating or guiding team members or vendors.
- Able to identify and resolve operational issues related to biomarker sample handling, shipment, and analysis.
- Strong organizational and planning skills, with attention to timelines, data quality, and compliance.
- Proactive, independent, and detail-oriented, with good problem-solving skills.
Benefits
- Competitive remuneration packages
- Annual bonus
- Equity
- Generous Paid Time Off