Note: The job is a remote job and is open to candidates in USA. BeOne Medicines is seeking a Global Clinical Study Manager to lead the delivery of global oncology clinical studies. The role manages cross-functional teams and external partners, oversees study planning and execution from feasibility through closeout, and ensures compliance, inspection readiness, quality, timelines, and budgets.
Responsibilities
- Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality
- Leads all aspects of assigned clinical study(ies)
- Leads global cross-functional study team (including oversight of external partners) and acts as point of escalation for resolution of issues within assigned study(ies)
- Ensures alignment of study goals with clinical operations and corporate goals and objectives
- Leads the global cross-functional study team effectively, ensures effective decision making, and acts as point of escalation for resolution of study related issues
- Leads external vendors management involved in study delivery
- Builds trust and relationship with regional subject matter experts and supports the delivery of their local study objectives
- Collaborates with key stakeholders across the organization and provides regular updates on study progress to senior management as required
- Represents the study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings
- Participates and presents at various topics of Clinical Study Management
- Participates in Clinical Operations Process improvement initiative
- Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities
- Generates, manages, maintains, and communicates high quality study timelines and tracks progress towards these
- Ensures that the clinical studies are operationally feasible along with Global Clinical Program Lead, oversees trial feasibility, trial allocation and site selection process across all regions
- Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs
- Provides oversight to study start up and site activation plans
- Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ...) are created, updated and distributed timely and implemented appropriately
- Ensures study systems and tools are set up timely, correctly and are functioning properly. Ensures study level information is updated on an ongoing basis in all systems
- Implements RBQM end-to-end processes on time within the allocated study (e.g., periodic reviews, centralized monitoring analyses, action items)
- Ensures relevant study specific training is developed and implemented and ensures training records are well documented and filed
- Ensures Trial Master File for study is created, maintained and QC’d on a regular basis as per the study TMF QC plan
- Collaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sites
- Supports and as needed drives overall data cleaning timelines in close collaboration with Data Management and other stakeholders (including but not limited to regional clinical operations teams and medicator monitor)
- Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST members
- Monitors study activities to ensure compliance with the study protocol, SOPs, all study plans, ICH/GCP and all other relevant regulations
- Regularly reviews and manages quality-related GCO metrics to be within acceptable limits
- Ensures inspection readiness at any point in time throughout the study life cycle
- Works with cross-functional study team to identify, interpret, and evaluate issues on the study and ensures corrective and preventative actions are implemented
- Ensures senior management and other key stakeholders are informed of risks and challenges and ensures risk mitigation plans are put in place and implemented
- Prepares team for quality assurance audits and inspections
- Collaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared
- Leads improvements and partners with study team members to enhance the efficiency and the quality of the work performed on assigned studies
- Contributes to development, optimization and review of work instructions and SOPs as required
- Works with the sourcing team to select and manage study vendors, approving invoice payment throughout the study
- Manages study budgets, including baseline budget evaluation, change control, study closure budget, presents study budget for senior management engagement
- Adheres to clinical study budgeting processes and provides input to finance on budget accruals and forecasts
- Identifies and manages study team resource needs and establishes contingency plans for key resources
- Monitors Clinical Study Team resource utilization over the study life cycle
- Ensures clinical studies at a project level are executed within endorsed time, quality, and cost parameters
Skills
- MS Office, Project Planning Applications, Clinical Trial Management Systems
- Proven Project Management experience in Global Clinical Studies
- Advanced knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes
- Able to independently lead global clinical studies
- 6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry
- Bachelor's Degree in a scientific or healthcare discipline required
- Exceptions might be made for candidates with relevant clinical operations experience
- Oncology experience preferred
- Higher Degree preferred
Benefits
- Non-Commercial roles are eligible to participate in the annual bonus plan
- All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards
- All employees may voluntarily participate in the Employee Stock Purchase Plan
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Company Overview
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