
Clinical Study Manager
BeOne Medicines
Clinical Study Manager
BeOne seeks a Clinical Study Manager for hybrid role in Netherlands to lead regional clinical study delivery, ensuring quality, timelines, and budget. Requires 7+ years clinical research experience with 2 years study management, and a scientific or healthcare degree.
HybridFull-timeSeniorMS OfficeProject Planning Applications
Clinical Study Manager
BeOne seeks a Clinical Study Manager for hybrid role in Netherlands to lead regional clinical study delivery, ensuring quality, timelines, and budget. Requires 7+ years clinical research experience with 2 years study management, and a scientific or healthcare degree.
HybridFull-timeSeniorMS Office
Salary
Not specified
Core Qualifications
Technical (Must-have)
MS OfficeProject Planning Applications
Soft Skills
CollaborationDecision MakingProblem SolvingAnalytical ThinkingInitiativeTeamworkCommunication
Key Responsibilities
- Accountable for region/country study delivery with inspection readiness quality, within agreed timelines and budget
- Leads the regional/country clinical operations team including oversight of external partners
- Ensures alignment of regional/country deliverables with overall study goals
- Leads planning and management of assigned clinical study from feasibility through closeout
- Generates, manages and maintains high-quality study start-up and recruitment timelines
- Ensures clinical study is operationally feasible in region/country, drives trial feasibility, country allocation and site selection
- Provides regional/country input on global/regional study plans
- Ensures timely availability of local adaptations of global/regional study documents
- Accountable for submissions of study in assigned region/countries
- Ensures regional/country information in study systems and tools is entered and up to date
- Collaborates closely with CRAs to ensure proper study execution at sites, reviews and signs off on monitoring reports
- Responsible for working with regional/country teams to ensure TMF is created, maintained and QC'd regularly
- Provides input to Global Clinical Supplies regarding drug inventories and reviews local drug labels
- Manages trial data collection process for region/country, drives data entry and query resolution
- Supports planning and execution of Clinical Study Report as required
- Handles escalated issues or problems with sites in region/country
- Monitors study activities to ensure compliance with protocol, SOPs, ICH/GCP and regulations
- Ensures inspection readiness for study in region/country
- Informs Global/Region focused Clinical Study Manager of issues and ensures solutions implemented
- Prepares sites for audits and inspections, drives responses to findings
- Collaborates to ensure cross-team, site learnings and best practices are shared
- Leads improvements and partners with CST members to enhance efficiency and quality
- Contributes to development, optimization and review of work instructions and SOPs
- Works with sourcing team to select and manage regional/country study vendors
- Manages regional/country study budgets
- Works closely with Clinical Business Operation on investigator fees and site payments
- Identifies and manages regional/country team resource needs and establishes contingency plans
- Monitors regional/country resource utilization over study life cycle
Clinical Study ManagerPharmaceuticalClinical ResearchHybridNetherlandsFull-timeSeniorCROBiotechOncology