Clinical Study Manager
Employment Type: Full-Time
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.
* Leads all aspects of assigned clinical trial(s) and demonstrates a high level of knowledge of clinical operations' methodologies, organizational, project management and leadership capabilities
* Works to ensure adherence to a standardized approach to clinical trial management
* Manages clinical trial projects through leadership of and delegation to a cross-functional study execution team (CST), working under the guidance and direction of the Clinical Program Lead. Ensures successful clinical trial planning, execution and delivery - within specified quality, time and cost parameters
* Exhibits a strong understanding of methodologies and approaches, ensures alignment of clinical project goals with Clinical Operations program objectives
* People management which includes performance oversight and development, quarterly check-ins and year-end performance reviews
* Mentoring of team members
* Ensures that TMF for assigned clinical trial(s) is created, maintained, monitored, and closed out on a timely basis
* Ensures site monitoring reports are accurate and thorough, reviewed on a regular basis and that metrics are being adhered to
* Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance
* Manages Central Lab and ancillary vendors selection, set-up, conduct, and close-out for BeiGene studies.
* Oversees and/or delegates the management and oversight of study vendors (CRO) to ensure that BeiGene's clinical trials are getting the necessary resources and attention the vendor has committed to, ensures trial deliverables and performance goals are met.
* Adheres to and contributes to the development and review of Clinical Operations Work Instructions and SOPs
* Escalation point person to Clinical Program Lead and Program Management Lead when necessary.
* Oversees the development of and adherence to clinical trial project timelines and ensures senior Clin Ops staff, DCT, and line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
* Ensures accurate and comprehensive completion of documents needed for Health Authority submissions by working with Regulatory Affairs to establish timeframes for submissions and ensure clarity of documentation required
* Coordinates the relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection) with other BeiGene functions (primarily those represented on CST) to support clinical trials delivery within the drug development process
* Coordinates with Clinical Supply Chain regarding drug forecasting and supply of drug products to sites
* Supports timely and efficient database lock by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts
* Ensures that external partnerships (e.g. CRO) are effectively supporting clinical trials, within contracted terms including budget; is the primary point of contact for CRO partners
* Oversees the administration of invoice reconciliation, scoping, and change orders, for clinical trial operations
* Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecasts
* Participates in clinical trial scenario planning (estimates time and cost)
* Leads matrix, multi-disciplinary, cross-functional study execution teams (CST) from start-up through close-out to ensure both internal and external deliverables are on time and on budget
* Ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity
* Leads cross functional team to ensure timely activation of clinical trials; including risk management and problem-solving
* Proactively identifies, negotiates and brokers solutions to clinical study issues that may arise
* Delegates and oversees the management of certain aspects of project management to junior staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters.
* Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans
* Conduct quarterly check-ins and year end performance appraisals for direct reports which includes providing ongoing and constructive feedback
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
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, 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 budget.
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
* Bachelor's degree or higher in a scientific or healthcare discipline preferred.
* 3-5 years of progressive experience in clinical research or clinical operations within the biotech, pharmaceutical sector or CRO industry.
* Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required.
* Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required.
* Proficient written and verbal communication skills.
* Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
* Management experience of CROs, Vendors and Consultants preferred.
* Therapeutic or medical knowledge preferred
* Regulatory authority inspection experience a plus
* Strong written and verbal communication skills.
Travel: up to 10-15%
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, non-disqualifying physical or mental 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.