Clinical Trial ManagerLocation London, United Kingdom Apply
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 Manager is an essential position within Clinical Operations providing oversight of the CLO study team, vendors and CRO in support of BioMarin’s Therapeutic Area Strategy. Specifically, the Clinical Trial Manager holds the role of Study Operations Lead and is accountable for day-to-day Clinical Operations activities and deliverables associated with clinical trial execution. They serve as the primary point of contact within Clinical Operations for a study.
Note: The Clinical Trial Manager my also serve in the role of Regional Operations Lead (ROL) for a global, multi-country study. Details of the ROL role are outlined by the Study Operations Role as required by study.
Following demonstrated success in the Study Operations Lead role, the Clinical Trial Manager may have the opportunity to take on the Cross-functional Study Execution Team Lead (SETL) role for a Study Execution Team with earlier stage or lower complexity studies.
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:
Risk Assessment & Mitigation:
Drug or Investigational Product (IP):
Clinical Governance / Team Membership and Leadership:
The Manager may have an opportunity to manage up to 2 direct reports, depending on business needs.
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.
5+ years pharmaceutical industry experience; clinical research preferred.
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.