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Clinical Trial Specialist (TEMPORARY)

Location San Rafael, California
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 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. 

Duties


We are currently looking for the best and brightest talents to join our team. The ideal candidate would be a clinical research professional passionate about operations with a minimum of 2 years’ experience in Clinical Operations, focused on working to ensure delivery of quality data, and committed to helping our patients. A proactive problem solver who shows flexibility and an ability to communicate at all levels of an organization.


The Clinical Trial Specialist performs essential responsibilities for successful trial execution at BioMarin. The Clinical Trial Specialist takes on the key role of Study Specialist, contributing to tasks related to site management and/or study management and oversight activities as delegated by SETL, Study Operations Lead (SOL), or Regional Operations Lead (ROL). This may include contributing to and/or supporting study matters that impact study timelines, quality and budget.


The Clinical Trial Specialist can be partly or fully responsible for the following areas depending on his/her level of proficiency. Responsibilities may include, but are not limited to:



Assist with study coordination activities



    • Conduct study tracking support (e.g., CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates

    • Assist with inspection readiness activities

    • File, track and maintain TMF

    • Maintain internal/external contact list

    • Conduct electronic documentation and records management

    • Perform document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, payments, invoices, and other study documentation

    • Execute meeting logistics (e.g., meeting minutes, expense reports, and travel coordination)

    • Ensure timely study entry and updates to ClinicalTrials.gov

    • Prepare investigator meeting materials

    • Design and prepare study related materials for the training of internal and external staff



Assist or lead in study conduct activities


Start-up: 



    • Facilitate CDA and contract execution.

    • Assist with regulatory package review

    • Request and distribute insurance certificates for sites – as delegated by, and under the oversight of, Study Lead

    • Contact and identification of investigators for participation in clinical studies Provide administrative assistance with internal and external meetings including investigator meeting(s)

    • Assisting in the management of CRO deliverables (from meeting minutes to finalized ICF)

    • Ensure accurate study entry and updates to ClinicalTrials.gov throughout life of study



Enrollment and Maintenance:



    • Issues identification, resolution, and escalation

    • Track site payments and vendor invoices

    • Track patient status

    • Review of study ICFs and other study documents

    • Assist with samples reconciliation and query resolution

    • Conduct MVR review and appropriate escalation of identified issues

    • Assist with MVR tracking and filing of sponsor comments

    • Identify issues, with potential resolution, and escalate when appropriate



Closure:



    • Conduct study closure activities (sites, reconciliation activities, filing & archiving)

    • Track, collate clinical trial documentation related to CSR appendices Cross-functional Representation

    • Assist with cross-functional meeting coordination and minutes

    • Assist study supplies management

    • Lead TMF close-out activities, including document review, uploading and reconciliation


Skills




The Clinical Trial Specialist is expected to be in the process of developing foundational competence in critical areas required for success in Clinical Operations across Communication and Collaboration, Proactivity and Adaptability, Strategic Thinking, Planning and Analysis, and Problem solving and Decision Making. For example:



    • Responds promptly with clear, organized written and oral communication

    • Seeks out, and understands the value of, opportunities to interact with peers and stakeholders; builds a network of internal and external peers

    • Takes ownership and accountability for completing assigned tasks and perseveres through obstacles

    • Embraces new challenges or changed priorities and adjusts plans and priorities accordingly


The Clinical Trial Specialist is also in the process of developing foundational technical competence in Study Management and Execution, Compliance and Quality, Drug Development and Study Design, and Product and Therapeutic Area Knowledge.

Education


BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.


2+ years pharmaceutical industry experience



We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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