Senior Clinical Study Manager (SCSM)
BeiGene, San Mateo, CA
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BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 2,200 employees in China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, please visit www.beigene.com.
- Responsible for the planning, implementation and conduct of large, global, complex oncology clinical trials in Phase I-IV; or multiple smaller early-phase studies.
- Provides leadership within the department and makes recommendations with regards to the operational aspects of executing clinical development deliverables.
Essential Functions of the Job:
Clinical Trial Management
- Responsible for oversight and project management of individual studies as well as relevant program related activities with minimal supervision.
- Manage CROs, vendors and consultants that are involved with the clinical trial and program.
- Serve as the clinical operations point person managing protocol execution.
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
- Participate in program strategy meetings, ad hoc clinical operations' initiatives and programs as assigned.
- Assist with training and mentoring of internal BeiGene clinical operations staff.
- Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs.
- Assist in preparation of clinical documentation for IND submissions/updates as well as NDA submission and other regulatory submissions as appropriate.
- Oversees the review and approval of clinical monitoring visit reports and ensures that all outstanding follow-up items are closed out in a timely manner.
- Review and provide input for reports and clinical documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates.
- Manage escalation of study related issues and establish appropriate course of action with Senior Management.
- Liaises with the clinical supply chain lead to ensure forecasting of clinical and non-clinical supplies accurately reflects protocol/trial needs.
- Ensure that the Clinical Trial Master File (TMF) is set up and maintained appropriately throughout the trial.
- Conduct periodic reviews of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed.
- Participate and respond to Quality Assurance and/or regulatory authority inspection audits.
- Ensures quality clinical data review and data integrity for assigned clinical trial(s)
- Leading, overseeing and participation in governance committees (eg: CST, DCT, JOC)
Fiscal and Contracts Management
- In conjunction with legal group and/or CRO facilitate the development of clinical trial agreements and other relevant documents.
- Review and approve site budgets, manage clinical trial budgets, liaise with finance when financial reporting and projections are requested from management.
- Liaise with Strategic Clinical outsourcing and participate in CRO bid defense meetings and vendor selection activities to include: creation of scope of work, budgets, vendor performance and issue resolution.
- Reconcile and report vendor and site payments, and change orders ensuring accuracy and timely delivery to finance.
- Responsible for creating program-level budget(s).
Cross Functional Mentoring and Leadership
- Work cross-functionally to ensure clinical program timelines and goals are met.
- Provide study-specific mentoring and line management for junior team members, as appropriate.
- Assume leadership role in operational improvement initiatives (e.g. SOP development, training etc.)
- Bachelor's degree in health sciences or related field
- Minimum of 5-7 years' experience in clinical research with at least 3 years' experience in Project Management or Clinical Monitoring preferred. Prior experience participating in a Regulatory Authority inspection strongly preferred.
- 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
- Bachelor's degree or higher in a scientific or healthcare discipline preferred with minimum of 5-7 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, or CRO environment. Prior experience managing people is needed.
Travel: up to 10-25%
- Ensures the competencies and skills required for the Clinical team is consistent with the company defined requirements
- 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
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