Sr. Clinical Trial Specialist, Clinical Operations
San Rafael, CA
Who We Are 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 Culture 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 \u2013 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\u2019s 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\u2019 lives. The BioMarin Clinical Operations/Global Study Execution function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.\u00A0Role SummaryThe Sr. Clinical Trial Specialist (CTS) contributes to or leads tasks related to the oversight of site monitoring, site management and/or vendor management, and other activities as delegated by the Study Manager or Clinical Program Lead (CPL). This may include contributing to and/or supporting study related matters that impact study timelines, quality, and budget. The Sr. CTS will demonstrate a greater level of independence in executing assigned tasks and will take on more challenging or complex vendors and sites, sites with Primary Investigator relationship management complexity, or a larger number of sites in a region. Within the role the candidate is expected to show and have proficient knowledge and experience in the following core competencies: Agility and Proactivity Leadership Communication and CollaborationWith advanced knowledge and experience in the following technical competencies: Study Management and Execution Compliance and Quality Drug Development and Study Design Product and Therapeutic Area Knowledge\u00A0Responsibilities include but are not limited to: Study Start Up Develop study specific documentation, as delegated by the Study Manager Contribute to the management of country and site feasibility assessment Provide support in the management of Regulatory document collection and tracking for participating sites Contribute, as required, to the management of IRB/EC related activities from submission to approval Confirm that all site level documents have been collected to support site initiation Contribute to the IP release process Prepare site staff/CRO training and investigator meeting materials and present at investigator meetings as assigned Ensure timely study entry and updates to ClinicalTrials.gov Ensure investigator payment: site setup, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor) Provide administrative assistance with internal and external meetings including investigator meeting(s) May arrange study specific printing (mini protocols) Facilitate Screening Authorization Forms tracking/sign off when applicable Assist with IP Pack Release Form review QC checks Manage various Clinical Operations document translations Process documents for signature in DocuSign Site management for delegated site(s) Vendor Oversight Team Membership and Leadership Attend internal Clinical Operations team meeting, vendor meetings, and/or sub team meeting(s) and take meeting minutes as requested Ad hoc attendance at SET Meetings, as required Clinical Trial Insurance Investigation Product (IP) Support Study Manager to ensure timely delivery of IP to the sites, in collaboration with CSC representative \u2022 Ensure that CRO/sites are on IP handling according to pharmacy manual Study Closeout Other Responsibilities Create/maintain essential document trackers Trial Master File (TMF): input into eTMF content list, file documents, and conduct comprehensive TMF review = Assist with filing of study documents in internal systems Contribute to Clinical Operations risks identification and mitigations\u00A0Education & Experience BA/BS or higher in nursing, life or health sciences is preferred.\u00A0 Industry or relevant experience in lieu of education is considered. Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.) 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.
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