Senior Global Clinical Study Manager

BeiGene

8d•$136,400 - $181,400

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 Contributes to development of global tools and standards, leads the development of work instructions and SOPs as required

Requirements

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
7+ or more years of progressive experience in clinical research within biotech, pharma or CRO industry
MS Office, Project Planning Applications, Clinical Trial Management Systems

Nice To Haves

Higher Degree preferred
Oncology experience 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
Leads 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
Mentors junior team members