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New Mexico, United States
Remote only
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.
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 accommodationsus@beonemed.com.
