Global Clinical Study Senior Manager

BeOne Medicines; Emeryville (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

BeOne Medicines in Emeryville, CA seeks a Senior Global Clinical Study Leader to own end-to-end global operational delivery of one or more clinical studies. You will lead regional and external partners, drive timelines, enrollment, quality and budget, and serve as the single accountable owner for study execution.

You will mentor regional study managers, ensure cross-functional alignment with Medical, Regulatory, Biometrics and Supply, and oversee start-up, site activation, data flow and TMF

Qualifications

• Over 5 years’ project management in clinical trials within biotech/pharma CRO sectors or relevant field.
• Experience leading regional clinical study managers and cross-functional teams.
• Proven ability to drive timelines, enrollment, quality and budget across global studies.

Responsibilities

• Leads the global clinical operations team and acts as point of escalation for region-specific issues.
• Owns study execution as the single accountable owner for timelines, enrollment, quality and budget.
• Ensures global consistency while enabling regional execution flexibility and maintains study materials and TMF quality.

Skills

Leadership

Stakeholder management

Risk management

Strategic thinking

Education

Bachelor’s Degree in a scientific or healthcare discipline

Tools

MS Office

Project Planning Applications

Job description

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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.