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Senior 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


BioMarin is a pioneer and a world leader in Rare Diseases. In 2017, we celebrated 20 years of bringing life changing therapies to our patients, many whom are children.

CenterWatch, a leading source for global clinical trial information, has named us one of the fastest drug developers in the industry. On average, we can bring treatments to market 12 months faster. For our patients, one year can make a lifetime of a difference. Clinical Operations plays a critical part in creating a sense of urgency tied to our purpose: To deliver new therapeutic options, as fast as we can, to our patients by ensuring proper planning, conduct, monitoring and data quality from study start-up to close-out. Our department is proud to foster rich communication and collaboration between study sites, and key stakeholders in the clinical trial ecosystem.

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 up 4 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 efficiently.

The Sr. Clinical Trial Specialist (Sr. CTS) performs essential responsibilities for successful trial execution at BioMarin. He/She takes on the key role of Study Specialist in the operational team, contributing to, or leading tasks related to study management and oversight activities. This may include contributing to and/or supporting study matters that impact study timelines, quality and budget.

Following demonstrated success in the Study Specialist role, the Sr. Clinical Trail Specialist may have the opportunity to take on regional operations responsibilities including managing issues and opportunities that impact regional study timeline, quality and budget; overseeing the CLO team, vendors and CRO for the study in the region; and escalating regional decisions, issues and risks.

Key responsibilities for this position include:

Quality:

  • Manage and track vendor adherence to SOW and oversight plan for assigned vendors
  • Lead protocol deviation meetings, if assigned

Timelines:

  • Contribute to or be responsible for the development of vendor specific timelines ensuring alignment with study level timelines

Contracts & Budgets:

  • Manage Change Order and Change Negotiation Form (of vendors) processes, in collaboration with Business Operations
  • Review and approve invoices for assigned vendors
  • Ensure investigator payment: site setup, pass-through processing, visit payment processing and funding processing

Clinical Operations Managed Vendors & CRO:  

  • Drive day-to-day management of assigned vendors
  • Communicate study performance expectations to vendors, manage and track vendor performance metrics at a study level

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

Skills


The Senior Clinical Trial Specialist is expected to have foundational competence in critical areas such as Communicationand Problem solving. You are also expected to be proactive and able to make decisions. 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 Senior Clinical Trial Specialist has 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.

4+ 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.

About our location

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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