Regional Clinical Study Manager

Overview

BeOne continues to grow with opportunities for experienced professionals. We seek scientific and business professionals who are motivated, collaborative, and passionately interested in fighting cancer.

Responsibilities

• Accountable for regional study delivery with inspection readiness quality, within agreed timelines and budget.
• Lead the regional clinical operations team, including oversight of external partners, and act as point of escalation for issues within the region for the assigned study.
• Ensure alignment of regional deliverables with overall study goals.
• Lead the regional clinical operations team effectively, enable decision making, and escalate regional issues as required.
• Lead external vendors involved in study delivery on a regional level.
• Collaborate with regional stakeholders and provide regular updates on study progress to senior management and the Global Clinical Study Manager as required.
• Represent the regional study team at internal and cross-functional Clinical Study Team (CST) meetings; lead regional operations meetings with the regional study team.
• Plan and execute the assigned clinical study(ies) from feasibility through closeout for the region, in line with global timelines.
• Generate and maintain high quality start-up and recruitment timelines for the region; track progress toward these targets.
• Ensure operational feasibility in the region, drive trial feasibility, country allocation, and site selection in collaboration with feasibility managers, country heads, medical affairs, and other stakeholders.
• Provide regional input on global study plans and ensure timely local adaptations of global study documents (e.g., informed consent forms) for regulatory submission and EC/IRB approvals.
• Oversee submissions of studies in countries within the region in collaboration with the regional start-up team and regulatory affairs.
• Maintain accurate regional and country information in study systems; collaborate with CRAs to ensure proper site execution and sign-off monitoring reports.
• Ensure the TMF for country and site levels is created, maintained, and QC’d according to the TMF QC plan.
• Provide input to Global Clinical Supplies on regional drug inventories and review local drug labels; assess local regulatory approval and reimbursement status of comparator drugs.
• Manage the regional trial data collection process, drive data entry and resolve queries.
• Support planning and execution of the Clinical Study Report in collaboration with the Global Clinical Study Manager and Medical Writing as needed.

Quality

• Handle escalated issues with sites in collaboration with stakeholders (country heads).
• Monitor study activities to ensure compliance with the protocol, SOPs, ICH/GCP, and applicable regulations.
• Ensure inspection readiness for the region throughout the study lifecycle.
• Inform the Global Clinical Study Manager of issues, evaluate impact, and implement solutions.
• Prepare sites for quality assurance audits and inspections; drive responses to findings.
• Collaborate with CST members to share learnings and best practices; lead improvements to enhance efficiency and quality for assigned studies.
• Contribute to development and review of work instructions and SOPs as required.

Budget and Resources

• Work with the sourcing team to select and manage regional study vendors.
• Manage regional study budgets; coordinate investigator fees, site payments, and patient travel reimbursements.
• Identify and manage regional team resource needs and establish contingency plans for key resources.
• Monitor resource utilization over the study lifecycle and liaise with functional managers as needed.

Education

Required: Bachelor’s Degree in a scientific or healthcare discipline. Higher degree preferred. Exceptions may be made for candidates with relevant clinical operations experience.

Other Qualifications

• 4+ years of progressive experience in clinical research within biotech, pharma, or CRO industry.
• Proven experience in clinical research including leadership of a clinical function; CRA experience is preferred.
• Supervisory responsibilities include providing performance feedback and mentoring junior team members as required.

Technical Skills

• Efficient in Microsoft Word, Excel, MS Project, PowerPoint, and Outlook.

Travel

Travel may be required as per business needs.

Salary Range

France: 74,100 EUR – 92,600 EUR.

Global Competencies

• Patients First, Driving Excellence, Bold Ingenuity, Collaborative Spirit
• Fosters Teamwork; Provides and Solicits Honest and Actionable Feedback
• Self-Awareness; Acts Inclusively; Demonstrates Initiative
• Entrepreneurial Mindset; Continuous Learning; Embraces Change
• Results-Oriented; Analytical Thinking/Data Analysis
• Financial Excellence; Communicates with Clarity

EEO and About BeOne

We are an equal opportunity employer. BeOne does not discriminate on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis protected by law. All employment decisions are based on qualifications, merit, and business need.