Global Ciinical Study Senior Manager

BeiGene 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.

Position Summary

• Accountable for global study delivery with appropriate inspection readiness quality, within agreed timelines and budget
• Leads all aspects of assigned clinical 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
• 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)

Essential Functions Of The Job

Cross-Functional Leadership

• Builds trust and relationship with regional subject matter experts and supports the delivery of their local study objectives
• Represents the study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings
• 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
• Leads the global cross-functional study team effectively, ensures effective decision making and acts as point of escalation for resolution of study related issues

Planning and Execution

• 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
• 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)
• Generates, manages, maintains, and communicates high quality study timelines and tracks progress towards these
• Provides oversight to study start up and site activation plans
• Ensures relevant study specific training is developed and implemented and ensures training records are well documented and filed
• Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs
• Ensures Trial Master File for study is created, maintained and QC’d on a regular basis as per the study TMF QC plan
• Ensures that the clinical studies are operationally feasible, oversees trial feasibility, trial allocation and site selection process across all regions
• 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 planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST members
• Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities
• Collaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sites

Quality and Risk Management

• Works with cross-functional study team to identify, interpret, and evaluate issues on the study and ensures corrective and preventative actions are implemented
• Leads development, optimization and review of work instructions and SOPs as required
• Ensures inspection readiness at any point in time throughout the study life cycle
• Prepares team for quality assurance audits and inspections
• Leads improvements and partners with study team members to enhance the efficiency and the quality of the work performed on assigned studies
• Ensures senior management and other key stakeholders are informed of risks and challenges and ensures risk mitigation plans are put in place and implemented
• Collaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared
• Monitors study activities to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations

Budget and Resources

• Adheres to clinical study budgeting processes and provides input to finance on budget accruals and forecasts
• 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
• Ensures clinical studies at a project level are executed within endorsed time, quality, and cost parameters
• Monitors resource utilization over the study life cycle
• Identifies and manages study team resource needs and establishes contingency plans for key resources.

Supervisory Responsibilities

• Mentors more junior team members and might take on line management responsibilities as required
• Provides performance feedback on team members as required

Competencies

• Managing Stakeholders
• Communicating Effectively
• Learning
• Mentoring
• Embracing Change
• Providing Leadership
• Driving Excellence
• Working in Teams

Computer Skills

MS Office, Project Planning Applications

Other Qualifications

• In depth knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes
• Proven project management experience
• Able to independently lead large and/or complex global clinical studies
• 8 or more years of progressive experience in clinical research within biotech, pharma or CRO industry

Travel

Limited travel required

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

Competencies

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene’s Code of Business Conduct and Ethics, policies and procedures.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and within budget.

Salary Range: $133,000.00 - $178,000.00 annually

BeiGene 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, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeiGene 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. All employment is decided on the basis of qualifications, merit, and business need.