Global Clinical Study Manager

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
·    Experience in managing global oncology studies; preferably pivotal studies and inspection management with Hiring Authority.
 

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