CW) Sr. Study Specialist CONTRACT

Bio Marin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997.

Our revolutionary treatments for conditions such as achondroplasia, PKU, CLN2, Batten disease, MPS, Fabry disease, and Pompe disease provide new possibilities for patients and families who previously had few or no available options. Our commitment to excellence, patient needs, scientific expertise, and world‑class manufacturing capabilities drives the development of first‑in‑class therapeutics for rare genetic conditions.

From research and discovery to post‑market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams develop first‑in‑class and best‑in‑class therapeutics that provide meaningful advances to patients living with rare diseases.

The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). The SS supports study participant safety, data integrity, study timelines, quality, and budget, and demonstrates a greater level of independence in executing assigned tasks.

• Agility and Proactivity
• Leadership
• Communication and Collaboration

• Study Management and Execution
• Compliance and Quality
• Drug Development and Study Design
• Product and Therapeutic Area Knowledge

• Develop study specific documentation as delegated by the Study Manager
• Contribute to the oversight of country and site feasibility assessment and site selection
• Oversee CRO for IRB/EC related submission/approval activities
• Oversee essential documents for study life‑cycle management
• Develop and oversee site and investigator training materials
• Present at investigator meetings as assigned
• Ensure accurate and timely study entry and updates to Clinical Trials.gov
• Facilitate Screening Authorization Forms sign‑off and oversee tracking, where applicable
• Process documents for signature in Docu Sign
• Oversee Clinical Trial Insurance
• Attend GSO team, vendor, and/or cross‑function study execution meetings as a GSO representative and take meeting minutes as requested
• Oversee and manage essential documents in the Trial Master File (TMF)
• Contribute to GSO risk identification and mitigations
• Provide support and administrative assistance with internal and external meetings

• BA/BS or higher in nursing, life or health sciences preferred (industry or relevant experience considered)
• Experience in a biotechnology or pharmaceutical company, overseeing external vendors including SOW and budgets

Note:

This description is not intended to be all‑inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.