Regional Clinical Study Senior Manager

BeOne Medicines USA, Inc.; United States; Remote; USD 136,000 - 181,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines Ltd. is seeking a Regional Clinical Operations Lead to manage regional delivery of clinical studies, ensuring inspection readiness and alignment with global goals.

You will lead regional teams, coordinate with external partners, and ensure timelines and quality standards are met. Responsibilities include feasibility, site selection, regulatory submissions, study planning, and cross-functional collaboration with CST and Medical Affairs.

Qualifications

• 6+ years of progressive experience in clinical research within biotech, pharma or CRO industry.
• Experience leading regional or cross-functional clinical operations teams.
• Experience as CRA is preferred.”

Responsibilities

• Leads regional clinical operations team and external partners to deliver studies on time and within budget.
• Ensures inspection readiness and regulatory compliance in the region.
• Coordinates country allocation, site selection, and feasibility in collaboration with stakeholders.
• Manages regional budgets and resources; escalates issues to senior management.

Skills

Clinical research experience

Team leadership

CRA experience preferred

Education

Bachelor’s Degree in scientific or healthcare discipline

Tools

MS Office

Project Planning Applications

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Position Summary

Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget. Acts as regional lead for multiple studies across an indication or across a program as required. Leads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned study. Ensures alignment of regional deliverables with overall study goals. Contributes to the development of regional tools and leads the development of work instructions and SOPs as required.

Essential Functions of the job

Regional Leadership

Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study. Leads external vendors involved in study delivery on a regional level. Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required. Represents the regional study team at internal meetings and at the cross‑functional Clinical Study Team (CST) meetings. Leads regional operations meetings with all regional study team members. Displays therapeutic area knowledge and expertise.

Timelines, Planning and Execution

Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines. Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress toward these. Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders. Provides regional input on global study plans as required. Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs. Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs. Ensures regional and country information in study systems and tools is entered and up to date.

Quality

Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads. Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations. Ensures inspection readiness for study in region at any point in time throughout the study life cycle. Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented. Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate. Collaborates with CST members and other colleagues to ensure cross‑team, site learnings, and best practices are shared. Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies. Leads the development, optimization and review of work instructions and SOPs as required.

Budget and Resources

Works with the sourcing team to select and manage regional study vendors. Manages regional study budgets. Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities. Identifies and manages regional team resource needs and establishes contingency plans for key resources. Monitors regional resource utilization over study life cycle and liaises with functional managers as needed.

Supervisory Responsibilities

Provides performance feedback on team members as required. Mentors junior team members and might take on line management responsibilities as required.

Computer Skills

MS Office, Project Planning Applications

Other Qualifications

6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry. Proven experience in clinical research including relevant experience as team lead in clinical functions. Experience as CRA is preferred.

Travel

Travel might be required as per business need.

Education Required

Bachelor’s Degree in a scientific or healthcare discipline required. Higher Degree preferred. Exceptions might be made for candidates with relevant clinical operations experience.

Global Competencies

• 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

Salary Range

$136,400.00 - $181,400.00 annually

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job‑related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non‑Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.

We are proud to be an equal opportunity employer.

BeOne does 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. All employment is decided on the basis of qualifications, merit, and business need.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit