Sr. Clinical Trial ManagerLocation San Rafael, California Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The Sr. Clinical Trial Manager (Sr. CTM) takes on a leadership role in clinical operations study teams to ensure the highest quality of clinical operations deliverables.
The Sr. CTM leads all day-to-day Clinical Operations functional activities associated with the execution of clinical trials. The Sr. CTM is responsible for oversight of the CLO Study Specialists and Clinical Trial Assistants activities , as well as Vendor Management of the Clinical Research Organizations (CROs), and any third-party specialty vendors associated with the studies. The Sr. CTM is capable of overseeing and executing on all delegated tasks associated with highly-complex global multi-country studies and working in an extremely cross-functional team based environment.
- Study Planning & Management
- Ensure timely and quality execution of study according to the protocol, study execution plan, and GCP guidelines (including BioMarin SOPs, ICH and FDA and other Health Authorities (HAs))
- Oversee study feasibility assessment activities (if applicable)
- Ensure timely development and finalization of key study plans and manuals as per the Study Team charter
- Contribute to the development and review of critical study documents, such as study protocol, eCRF, ICF, and others
- Identify CLO risks and mitigations and align with cross-functional Study Team on overall Risk Mitigation Plan
- Identify, resolve or, if necessary, escalate CLO issues that have a significant impact to overall study timelines, other functions, budget or quality to Study Team Lead as per Study Team charter
- Provide CLO study activity timeline and budget inputs to overall Study
- Team timeline and budget
- Lead cross-functional effort to define enrollment strategy and plan for the study
- Participate in strategic study planning meetings (such as DMC, advisory board, steering committee)
- Provide study status updates to the Study Team and Study Team Lead
- Vendor Management
- In collaboration with appropriate teams, oversee and approve vendor evaluation and selection
- Drive negotiations with CRO, lead bid defense meetings, analyze detailed financial drivers
- Oversee day-to-day management of CRO and vendors’ contracted activities as per oversight plans
- Work with Clinical Outsourcing and Analytics (COA) group to ensure final payments to vendors at study closure
- Study Conduct Startup:
- Lead site identification, qualification, selection and activation activities for the study, including activities such as site and staff training, site budgets, site ICF and coordination of site investigator contracts with Clinical Contract & Grants
- Plan and deliver IM in collaboration with other key stakeholders
- Enrollment and Maintenance:
- Ensure adherence to study enrollment strategy and plan
- Ensure adherence to monitoring plan
- Ensure adherence to monitoring oversight SOP
- Ensure timely site payments
- Work closely with specialty vendors to ensure samples are being received and analyzed according to study team/protocol expectations
- Oversee all study closure activities (sites, reconciliation activities, filing & archiving, and e/TMF related activities)
- Coordinate and oversee data listing reviews
- Ensure timely delivery of clinical documents for the CSR and appendices
- Study Team Leadership
- Lead the cross-functional Study Team on one or more studies
- Act as main contact for all CLO study activities and represent CLO on Study Team and associated sub-teams
- Ensure CLO responsibilities for any cross-functional deliverables are met throughout the study, including study close-out and delivery of CLO related appendices for finalization of CSR
- Oversee, train and mentor junior study team CRAs and CTAs on study.
- Prepare and communicate study dashboards of standard metrics (KPIs, SQMs) to routinely monitor team activities and ensure compliance to timelines, quality and budget.
- Manage protocol deviation reviews in collaboration with CLS
- Provide forecast for clinical supply, including ancillary supplies and comparator drugs
- Contribute expertise to departmental and cross-functional process improvement activities
- Oversee eTMF maintenance
- Keep team driving to be in a state of constant Inspection Readiness
- Non-Study Activities
- Lead departmental and cross-functional initiatives
- Participate in creation and/or revisions of department SOPs and work instructions
- 8 years of pharmaceutical industry and clinical research experience
- Flexible work from home arrangement
- Must be able to work Pacific Standard Time hours, with flexibility to begin at 7am PT on several days per week due to the global nature of the trials.
- Remote-based applicants may be considered if able to travel to the San Rafael, CA campus on a scheduled basis as needed (post-pandemic), and able to work Pacific Time hours (as above).
- Previous experience working in global environment
- Previous experience working with gene therapies, GMOs, or other types of biologics
- Previous experience working on trials utilizing risked based monitoring, decentralized trials, and data analytics
- Previous experience working in collaborative nature with data management, completing data listing reviews and analyzing data outputs, utilizing EDC
- History of successfully developing effective relationships with outside vendors, CROs, and large central labs
- Outstanding verbal communication skills which resulted in professionally communicating and guiding individual and team efforts related to Clinical Operations
- Demonstrated skills in negotiation, multi-tasking, organization and decision making
- Ability to travel to global sites required.
- Prior experience working on cross-functional teams in a lead capacity
- BA/BS or higher in nursing, life or health sciences is preferred.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.