Regional Clinical Study Manager

Role Summary

Regional Clinical Study Manager for BeOne Medicines. Responsible for regional study delivery with inspection readiness quality within timelines and budget, leading the regional clinical operations team and coordinating with external partners. Ensures regional deliverables align with overall study goals.

Responsibilities

• Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget
• Leads the regional clinical operations team (including oversight of external partners) and serves as escalation point for regional study issues
• Ensures alignment of regional deliverables with overall study goals
• Leads the regional clinical operations team effectively, ensures decision making, and escalation for regional study issues
• Leads external vendors involved in study delivery on a regional level
• Collaborates with regional stakeholders and provides regular updates on study progress to senior management and Global Clinical Study Manager
• Represents the regional study team at internal meetings and cross-functional CST meetings
• Leads regional operations meetings with all regional study team members
• Leads planning and management of the assigned clinical study(ies) from feasibility through closeout for the region
• Generates and maintains high-quality start-up and recruitment timelines for the region and tracks progress
• Ensures operational feasibility in the region, drives trial feasibility, country allocation and site selection in collaboration with feasibility managers, country heads, medical affairs, and stakeholders
• Provides regional input on global study plans
• Ensures timely local adaptations of global study documents (e.g., informed consent forms) for regulatory submission
• Accountable for submissions of study in countries in the region in collaboration with regional study start-up team and regulatory affairs
• Ensures regional and country information in study systems is up to date
• Collaborates with CRAs to ensure site execution; reviews and signs monitoring reports
• Ensures TMF creation, maintenance, and QC for regional/country teams
• Provides input to Global Clinical Supplies regarding region drug inventories and local regulatory status of comparator drugs
• Manages trial data collection for the region, drives data entry and query resolution
• Supports planning and execution of the Clinical Study Report as required
• Handles escalated site issues in collaboration with country heads
• Monitors study activities for protocol, SOP, ICH/GCP compliance
• Ensures inspection readiness for the region throughout the study lifecycle
• Informs Global Clinical Study Manager of issues, evaluates impact, implements solutions
• Prepares sites for quality audits and inspections; drives responses to findings
• Collaborates with CST to share cross-team learnings and best practices
• Leads improvements to enhance efficiency and quality of work on assigned studies
• Contributes to development, optimization, and review of work instructions and SOPs
• Works with sourcing to select and manage regional study vendors
• Manages regional study budgets
• Coordinates with Clinical Business Operations on investigator fees, site payments, and patient travel reimbursement
• Identifies and manages regional team resource needs; establishes contingency plans
• Monitors regional resource utilization and liaises with functional managers as needed
• Provides performance feedback to team members; may mentor juniors

Qualifications

• 4 or more years of progressive experience in clinical research within biotech, pharma, or CRO sectors
• Proven experience in clinical research including team leadership in clinical functions
• Experience as a CRA is preferred

Education

• Bachelor‚Äôs Degree in a scientific or healthcare discipline required; higher degree preferred
• Exceptions may be made for candidates with relevant clinical operations experience

Skills

• MS Office, Project Planning Applications

Other Qualifications

• Travel might be required as per business need

Additional Requirements

• Ethics, Planning/Organizing, Communication, Teamwork, Adaptability, Technical Skills, Dependability, Quality, Analytical, Problem Solving, Project Management competencies
• Global Competencies include teamwork, feedback, self-awareness, inclusivity, initiative, continuous learning, change readiness, results orientation, analytical thinking, financial acumen, and clear communication