(Senior) Manager, Biomarker Operations
On-site · Shanghai, Shanghai, China
Shanghai, Shanghai, ChinaOn-siteFull TimeSenior LevelBachelors DegreeEnterprise
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Enterprise
Job Summary
Senior Manager, Biomarker Operations responsible for leading end-to-end biomarker sample operations across Phase I–IV trials, coordinating cross-functional teams, managing HGR submissions and regulatory risk, ensuring compliant sample handling, vendor oversight, and timely, high-quality biomarker data delivery while maintaining ICH/GCP compliance and driving process improvements.
Required Qualifications
- Bachelor’s degree or higher in Clinical Medicine, Pharmacy, Nurse, Life Sciences, or related fields.
- GCP certificate is preferred
- 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.
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