Global Clinical Study Manager (gCSM)

BeiGene

1d

About The Position

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 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 Essential Functions of the job: Cross-Functional Leadership 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 Planning and Execution 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 Quality and Risk Management 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 Budget and Resources 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 Supervisory Responsibilities: NA Computer Skills: MS Office, Project Planning Applications, Clinical Trial Management Systems Other Qualifications: Proven Project Management experience in Global Clinical Studies (Oncology experience preferred) 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 Travel: Travel might be required as per business need. Education: Bachelor’s Degree in a scientific or healthcare discipline required, Higher Degree preferred.

Requirements

• MS Office, Project Planning Applications, Clinical Trial Management Systems
• Proven Project Management experience in Global Clinical Studies (Oncology experience preferred)
• 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, Higher Degree preferred.

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees