Associate Director, Global Clinical Study Management

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

· Provides technical coaching and/or mentoring to junior team members and partners.

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, including large and/or complex global clinical studies from early phase/dose escalation studies to phase III registration studies based on business needs.

· Serves as a strategic advocate for projects, offering innovative operational solutions to address risks and challenges, including active involvement in CDP development in collaboration with the GCPL and other key activities

· Generates, manages, maintains, and communicates high-quality study timelines and tracks progress toward these.

· Ensures that the clinical studies are operationally feasible along with GCPL , 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 (e.g., project management plan, monitoring plan, Trial Master File plan, data monitoring plan, etc.) are created, updated, and distributed timely and implemented appropriately

· Ensures study systems and tools are set up in a timely and correct manner and are functioning correctly. 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 the 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 supply 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 medical monitors)

· 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 and involvement in communication with health authorities on behalf of the GCO study management team if applicable.

· 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.

· Recommends and contributes to areas of exemplary practice and process enhancements and spearheads initiatives/task forces for optimizing processes.

· Leads development, optimization, and review of work instructions and SOPs as required and offers innovative operational solutions to address risks and challenges.

Budget and Resources

· Works with the sourcing team to select and manage study vendors, approving invoice payments throughout the study.

· Manages study budgets, including baseline budget evaluation, change control, study closure budget, present study budget for senior management endorsement.

· 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:

Provides technical coaching and/or mentoring to junior team members and partners with line managers to contribute to global study management team development.

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

· 8 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 Required:

• Bachelor’s Degree in a scientific or healthcare discipline required*,
• Higher Degree preferred

*exceptions might be made for candidates with relevant clinical operations experience

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• •Fosters Teamwork
• •Provides and Solicits Honest and Actionable Feedback
• •Self-Awareness
• •Acts Inclusively
• •Demonstrates Initiative
• •Entrepreneurial Mindset
• •Continuous Learning
• •Embraces Change
• •Results-Oriented
• •Analytical Thinking/Data Analysis
• •Financial Excellence
• •Communicates with Clarity

Salary Range: $143,300.00 - $193,300.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, dep