Clinical Trial Manager
Location United States, RemoteWorkstyle Remote Only Apply
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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 or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients’ lives.
The Clinical Trial Manager (CTM) takes on a leadership role in clinical operations study teams to ensure the highest quality of clinical operations deliverables.
The CTM is accountable for day-to-day Clinical Operations functional activities associated with the execution of clinical trials. The CTM is responsible for oversight of the CLO Study Specialists activities as well as Vendor Management of the Clinical Research Organizations (CROs), and any third-party specialty vendors associated with the studies. The 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.
- Provide input and guidance on operational considerations to protocol development and Lead impact analysis of protocol changes for cross-functional teams and contributing vendors and implement changes accordingly.
- 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 Clinical Program 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 regular study quality and progress updates to Study Team, Clinical Program Lead and other key stakeholders.
- Vendor Management
- Lead vendor selection activities for key study vendors and collaboration with appropriate teams to 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 governance 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:
- Manage input to, and implementation of, recruitment and retention strategy 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 CTS study team 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.
- Minimum of 5-8 years of pharmaceutical industry and clinical research experience
- Ideal candidate would be able to work part-time in San Rafael office and support Pacific Time hours, with flexibility to begin at 7am PT on several days per week due to the global nature of the trials.
- Strong 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 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.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.
In the U.S., the salary range for this position is $ 116,200 to $ 174,200 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.