Global Clinical Study Senior Manager

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.

General Description:

• Accountable for end-to-end global operational delivery of one or more clinical studies, ensuring execution excellence across all regions from study start-up through close-out.
• This role serves as the primary global operational owner, responsible for aligning cross-functional stakeholders, managing global study strategy execution, and driving performance against timelines, quality, and budget

• Leads the global 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 global deliverables with overall study goals
• Contributes to the development of global tools and leads the development of work instructions and SOPs as required
• The GCSM provides hands on leadership and oversight of global study teams, ensuring proactive risk management, clear decision-making, and consistent execution across regions

Essential Functions of the Job:

Global Study Leadership

• Leads the 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
• Serves as the single point of accountability for study execution (timelines, enrollment, quality, budget)
• Collaborates with key stakeholders in the region and provides regular updates on study progress to BU Clinical Operations Lead and BULT (Biotech Unit Leadership Team) as applicable
• Ensures global consistency while enabling regional execution flexibility
• Oversees key operational deliverables:
  • Study start-up strategy
  • Enrollment acceleration plans
  • Site activation timelines
  • Data flow and query resolution

Cross-Functional Leadership

• Provides oversight and direction to regional clinical study managers
• Ensures clear roles, responsibilities, and accountability across the study team
• Drives alignment across:

• Clinical Operations (regional teams / RCSMs)
• Medical, Regulatory, Biometrics, Supply, etc.

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 study based on regional feedback and tracks progress towards these
• Ensures that the clinical study is operationally feasible in all regions, 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
• Ensures timely availability 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
• Ensures information in study systems and tools is entered and up to date
• Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports
• Responsible for working with global teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular basis as per the study TMF QC plan
• Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region
• Manages the trial data collection process for the region, drives data entry and query resolution
• As required, supports planning and execution of the Clinical Study Report in collaboration with Biotech and Medical Writing

Quality:

• Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads
• Monitors study activities across study to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations
• Ensures inspection readiness for study at any point in time throughout the study life cycle
• Informs Clinical Operation Lead, BU 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

• Accountable for global study budget planning, tracking and forecasting
• Ensures efficient allocation of resources across regions
• Partners with finance and functional leads to manage cost vs. performance trade-offs
• Works with the sourcing team to select and manage  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

Stakeholder & Leadership Engagement:  

• Represents Study leadership at Cross-Functional reviews
• Communicates clear, concise and transparent study status updates
• Ensures leadership visibility to risks, trade offs and mitigation plans
• Mentors junior team members and support new team members during onboarding

Computer Skills:   

MS Office, Project Planning Applications

Other Qualifications:    

• Over 5 years’ project management in clinical trials within the biotech, pharmaceutical sector, CRO industry or relevant field
• Proven experience in clinical research including relevant experience as team lead in clinical functions

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

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• 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

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. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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 [email protected].