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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 (CTS), is a critical team member in Clinical Operations. As a CTS, you will have a unique opportunity to participate in a wide range of operational activities related to clinical trial execution. Expect also to contribute to or lead tasks related to study and site management during start-up, conduct and close-out. Other key responsibilities cover vendor management and oversight. Altogether, this position provides you with an exceptional foundation for your career and professional growth.

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:

Quality:

    • Ensure TMF filing and maintenance is routinely doneTimelines:
  • Contribute to the development of vendor specific timelines ensuring alignment with study level timelines

Contracts & Budgets:

  • Review and approve invoices for assigned vendors
  • Review investigator payment: site setup, pass-through processing, visit payment processing and funding processing.

Clinical Operations Managed Vendors:  

  • May participate in vendor selection
  • Escalate vendor performance and quality issues

Protocol & Informed Consent Form (ICF) Development Process:

  • Create and maintain tracker for future amendment changes
  • Actively contribute to the review of any changes to the ICF Master
  • Ensure alignment of country/site specific ICFs with ICF Master

Study startup, conduct and close-out:

  • A diverse set of operational responsibilities related to the startup, the conduct and the close-out of clinical trials.

Insurance:

  • Ensure an insurance policy is in place for the country and, if applicable, the individual clinical trial sites associated with the protocol and protocol amendments
  • Ensure the required information/documents needed to obtain insurance are made available to CTA

Oversee extensions of expiring policies and processing of certificates, as appropriate

Skills


The Clinical Trial Specialist is expected to be in the process of developing foundational competence in critical areas required for long term 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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San Rafael

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