Senior Global Clinical Study Manager

About the role

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.

Responsibilities

• 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

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
• 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
• Planner 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
• 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
• Makes sure study activities are compliant 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
• 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
• Maintains clinical studies at a project level within endorsed time, quality, and cost parameters
• Supervisory Responsibilities
• Mentors junior team members
• Computer Skills
• MS Office, Project Planning Applications, Clinical Trial Management Systems

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 7+ or more years of progressive experience in clinical research within biotech, pharma or CRO industry

Other Qualifications

• Travel might be required as per business need.

Global Competencies

• 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

$136,400.00 - $181,400.00 annually

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Equal Opportunity Employer

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.