Clinical Trial Specialist, Clinical OperationsLocation San Rafael, California Apply
Clinical Trial Specialist
Department / Cost Center:
Reports to (Job Title):
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’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.
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:
Contracts & Budgets:
Clinical Operations Managed Vendors & CRO:
Protocol & Informed Consent Form(ICF) Development Process:
Study Start Up:
Study Conduct And Close-out:
Drug or Investigational Product (IP):
Clinical Governance / Team Membership and Leadership:
TheClinical Trial Specialistis expected to be in the process of developing foundational competence in critical areas required for long term success in Clinical Operations acrossCommunication and Collaboration, Proactivity and Adaptability, Strategic Thinking, Planning and Analysis, and Problem solving and Decision Making. For example:
The Clinical Trial Specialist is also in the process of developing foundationaltechnical competence in Study Management and Execution, Compliance and Quality, Drug Development and Study Design, and Product and Therapeutic Area Knowledge.
BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for Clinical Operations has been defined and is available to employees of BioMarin.
No people management responsibilities
EDUCATION AND EXPERIENCE
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
WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 20 lbs. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Some travel may be required.
Computer work utilizing common business software programs and hardware solutions.
Internal: Clinical Operations team and Study Execution Team Members, Core Team personnel, GCP Compliance, other Clinical Operations personnel; Other BioMarin Worldwide Research and Development functional area personnel; BioMarin Senior Management
External:CRO personnel, other vendor personnel, counterparts or appropriate team members at partner companies, clinical sites