Clinical Trial Manager

BIOMARIN PHARMACEUTICAL ,
London, Greater London
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Job Description

Description BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. BioMarin's Development Sciences Operations (DSO) group is responsible for everything from research and discovery to post-market clinical development. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. BioMarin's Clinical Operations group ensures proper planning, conduct, monitoring and data quality from study start-up to close-out. The group is responsible for fostering effective communication and collaboration between study sites and BioMarin. SUMMARY DESCRIPTION The Clinical Trial Manager is an essential position within Clinical Operations providing oversight of the CLO study team, vendors and CRO in support of BioMarin's Therapeutic Area Strategy. Specifically, the Clinical Trial Manager holds the role of Study Operations Lead and is accountable for day-to-day Clinical Operations activities and deliverables associated with clinical trial execution. They serve as the primary point of contact within Clinical Operations for a study. Note: The Clinical Trial Manager my also serve in the role of Regional Operations Lead (ROL) for a global, multi-country study. Details of the ROL role are outlined by the Study Operations Role as required by study. Following demonstrated success in the Study Operations Lead role, the Clinical Trial Manager may have the opportunity to take on the Cross-functional Study Execution Team Lead (SETL) role for a Study Execution Team with earlier stage or lower complexity studies. KEY RESPONSIBILITIES: Responsibilities may include, but are not limited to: Quality: * Establish/create the study-specific oversight plans in collaboration with Business Operations * Drive the development and adherence to Clinical Operations owned study specific plans * Ensure protocol deviation meetings are conducted per plan * Facilitate internal audit / corrective and preventive action (CAPA) management: contribute to the resolution of CAPA / Quality Event (QE) input in Trackwise * Manage TMF filing of Clinical Operations study documentation * Conduct or participate in inspections readiness activities in collaboration with DSQ Timelines: * Develop the Clinical Operations study specific timelines including start up, enrolment, maintenance and close-out Contracts & Budgets: * Initiate Change Order (CO) and Change Negotiation Form (CNF) for vendors in collaboration with Business Operations * Ensure invoice review of vendors, track vendor spend against plan and provide vendor budget updates to SETL * Provide monthly accrual for vendors to SETL * Ensure investigator payment: site setup, pass-through processing, visit payment processing and funding processing in collaboration with DrugDev Clinical Operations Managed Vendors & CRO: * Ensure vendor oversight plan is created and maintained * Contribute to the selection of CRO and vendors * Contribute to the development of standard metrics used to routinely monitor study activities * Perform day-to-day management of the CRO and other vendor(s) as needed * Monitor all vendors/CRO performance, communicate vendor expectations, and track vendor performance metrics at a study level * Ensure that vendors/CRO are adequately trained to perform their functions * Escalate vendor/CRO issues to the SETL when appropriate Protocol & Informed Consent Form (ICF) Development Process: * If assigned prior to protocol finalization, provide input to the protocol development * Serve as protocol subject matter expert for assigned study or studies * Actively contribute to the review of amendments to the protocol * Ensure creation and maintenance of tracker for future amendment changes * Contribute to the review of amendments to the ICF Master * Develop country/site specific ICFs * Ensure alignment of country/site specific ICFs with ICF Master Study Start Up: * Translate study start up requirements into regional/local targets * Ensure development and review of study specific documentation * Lead country and site feasibility assessment, as appropriate * Select potential qualified sites to participate in the study * Lead confidentiality agreement execution, budget and contract negotiation with selected sites in collaboration with Legal and Business Operations * Ensure regulatory document collection and tracking is performed for sites participating in studies * Lead Institutional Review Board/Ethics Committee (IRB/EC) related activities from submission to approval * Confirm tha

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