Department: Global Clinical Operations
Reports To: Director of Clinical Operations
Bachelors 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.
- 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.
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.)
- 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
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
- 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
- Position will require some travel 10%-15%