Global Clinical Study Manager

1 week ago

Sydney, Australia BeiGene Full time

Employee

Full time

About the Company:
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 9,500 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.

General Description of the Job:
- Accountable for global study delivery with appropriate, inspection readiness quality, within agreed timelines and budget- 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 involved in study delivery-
- 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

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, 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- 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, ICH/GCP and all other relevant regulations- 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, budget endorsement by senior management- 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 resource utilization over the study life cycle- Ensures clinical studies at a project level are executed within endorsed time, quality, and cost parameters

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