Jadebiosciences
Sr./Clinical Trial Manager
Boston; Remote; San Francisco; Vancouver. Posted a month ago
The role
The Sr./Clinical Trial Manager supports the Director, Clinical Operations in the planning and operational execution of assigned clinical trials. This role coordinates study activities across cross-functional partners, clinical sites, CROs, and vendors to ensure trials are delivered on time and in compliance with regulations.
What you will do
- Support development and execution of study operational plans, timelines, and enrollment projections
- Perform vendor oversight including deliverables, performance metrics, and invoice review
- Maintain clinical trial budgets and forecasts
- Maintain study risk, issue, decision, and action logs
- Coordinate operational input for clinical documents like protocols and informed consent forms
- Oversee global or regional study start-up, site activation, enrollment, and closeout
- Support planning and conducting investigator meetings
- Responsible for monitoring oversight and reviewing monitoring reports
- Build working relationships with clinical sites, investigators, CROs, and vendors
- Oversee maintenance of an inspection-ready Trial Master File
Required qualifications
- Bachelors degree
- 10+ years of related experience for Sr Clinical Trial Manager
- 7+ years of related experience for Clinical Trial Manager
- Trial management within a biopharmaceutical company
- Ability to manage complex clinical trial activities, timelines, vendors, budgets, and risks
- Experience managing CROs and clinical vendors including laboratories, RTSM, EDC, and ancillary clinical technology
- Strong working knowledge of FDA regulations, ICH guidelines, and Good Clinical Practice
- Working knowledge of clinical protocol implementation, regulatory submissions, and Trial Master File requirements
Nice to have
- experience at a small startup
- global clinical trial experience
- Immunology and/or rare disease clinical trial experience
- Experience mentoring or providing day-to-day guidance to junior team members
About the company
Jade Biosciences is a clinical-stage biotechnology company focused on developing therapies for autoimmune diseases. Their pipeline includes candidates targeting cytokine APRIL and anti-BAFF-R and anti-IFN-β monoclonal antibodies.