BeOne is hiring a Regional Clinical Study Associate Manager

BeOne is looking for a Regional Clinical Study Associate Manager accountable for ensuring regional study delivery meets inspection readiness standards within agreed timelines and budget. You will manage the regional clinical operations team and act as the primary point of escalation for resolving issues within your region.

What You'll Do

• Manage the regional clinical operations team effectively, ensuring effective decision making and acting as the point of escalation for resolution of issues within the region.
• Lead external vendors involved in study delivery on a regional level.
• Collaborate with key stakeholders in the region and provide regular updates on study progress to senior management and the Global Clinical Study Manager.
• Represent the regional study team at internal meetings and at cross-functional Clinical Study Team meetings as applicable.
• Lead regional operations meetings with all regional study team members.
• Manage planning and execution of assigned clinical studies from feasibility through closeout activities for the region.
• Generate, manage, and maintain high-quality study start up and recruitment timelines for the region and track progress.
• Ensure the clinical study is operationally feasible in the region, managing trial feasibility, country allocation, and site selection.
• Provide regional input on global study plans.
• Ensure timely availability of local adaptations of global study documents such as informed consent forms.
• Oversee submissions of the study in countries within the assigned region in collaboration with the regional study start up team and regulatory affairs.
• Ensure regional and country information in study systems and tools is entered and kept up to date.
• Collaborate closely with CRAs in the region to ensure proper study execution at sites, reviewing and signing off on monitoring reports.
• Ensure the country and site-level Trial Master File is created, maintained, and regularly QC’d.
• Provide input to Global Clinical Supplies regarding drug inventories in the region and review local drug labels.
• Manage the trial data collection process for the region, driving data entry and query resolution.
• Support planning and execution of the Clinical Study Report in collaboration with the Global Clinical Study Manager and Medical Writing.
• Handle escalated issues or problems with sites in the region in collaboration with stakeholders.
• Monitor study activities in the region to ensure compliance with study protocol, SOPs, ICH/GCP, and all relevant regulations.
• Ensure inspection readiness for the study in the region throughout the study life cycle.
• Inform the Global Clinical Study Manager of any issues arising on the study, evaluate impact, and ensure solutions are implemented.
• Prepare sites for quality assurance audits and inspections, driving responses to audit and inspection findings.
• Collaborate with Clinical Study Team members to ensure cross-team learnings and best practices are shared.
• Lead improvements and partner with Clinical Study Team members to enhance the efficiency and quality of the work performed.
• Work with the sourcing team to select and manage regional study vendors.
• Manage regional study budgets.
• Work closely with Clinical Business Operations on investigator fees, site payment issues, and patient travel reimbursement.
• Identify and manage regional team resource needs and establish contingency plans for key resources.
• Monitor regional resource utilization over the study life cycle and liaise with functional managers as needed.
• Provide performance feedback on team members as required.

What We're Looking For

• Bachelor’s Degree in a scientific or healthcare discipline.

Nice to Have

• A higher degree.

Team & Environment

You will manage the regional clinical operations team, which includes oversight of external partners working on the regional level.

Benefits & Compensation

• Compensation: $96,300 - $131,300 annually.
• Eligibility for discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan.
• Medical, Dental, and Vision insurance.
• 401(k) plan.
• FSA/HSA accounts.
• Life Insurance.
• Paid Time Off.
• Wellness programs.

BeOne is proud to be an equal opportunity employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law.