What are the responsibilities and job description for the Sr. Study Specialist, Global Study Operations position at Joulé?
Job Title: Sr. Study Specialist, Global Study Operations
Location: San Rafael, CA
Type: Contract
Compensation: $55.00 - $61.24 hourly
Contractor Work Model: Hybrid (at least 2 days/week)
Joule is currently recruiting or a Sr. Study Specialist. Ideally, this candidate will have a minimum of a Bachelor's degree and a background in global study operations.
The ideal candidate will be tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.
Responsibilities include but are not limited to:
Skills:
Education:
Ref: #568-Clinical
Location: San Rafael, CA
Type: Contract
Compensation: $55.00 - $61.24 hourly
Contractor Work Model: Hybrid (at least 2 days/week)
Joule is currently recruiting or a Sr. Study Specialist. Ideally, this candidate will have a minimum of a Bachelor's degree and a background in global study operations.
The ideal candidate will be tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.
Responsibilities include but are not limited to:
- Develop study specific documentation, as delegated by the Study Manager Contribute to the oversight of country and site feasibility assessment and site selection.
- Oversee and manage essential documents in the Trial Master File (TMF) Contribute to Global Study Operations risks identification and mitigations.
Skills:
- Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.)
Education:
- BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
Ref: #568-Clinical
Salary : $55 - $61