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

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

Salary Range: $136,400.00 - $181,400.00 annually 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