Regional Clinical Study Senior Manager

BeOne Medicines; Emeryville (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

BeOne Medicines is seeking a Regional Clinical Operations Lead to drive regional study delivery with inspection readiness and on-time/budget adherence. This role leads the regional operations team and external vendors to ensure successful delivery across studies within the designated indication or program.

The candidate will oversee feasibility, country allocation, site selection, and collaboration with stakeholders to align regional deliverables with global study goals, while driving quality

Qualifications

• 6+ years of progressive experience in clinical research within biotech, pharma or CRO
• Proven experience as team lead in clinical functions
• Experience as CRA is preferred

Responsibilities

• Leads the regional clinical operations team and acts as regional lead for multiple studies
• Manages external partners and ensures alignment with study goals and timelines
• Ensures inspection readiness and compliance with ICH/GCP and regulatory requirements
• Oversees planning, feasibility, site selection, and country allocation for the region
• Provides regular progress updates to senior management and CST meetings
• Manages regional budgets, resources, and vendor relationships

Skills

Leadership

Stakeholder communication

Decision making

Cross-functional collaboration

Education

Bachelor's degree in a scientific or healthcare discipline

Higher degree preferred

Tools

MS Office

Project Planning Applications

Job description

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 towards 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
• 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 regional and country 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 Global Clinical Study Manager 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 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 othercolleagues 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 cyle 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

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.