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About the Role
The Sr/Clinical Trial Manager will support the Director, Clinical Operations, in planning and executing assigned clinical trials. This role involves coordinating study activities, managing plans, timelines, budgets, and risks, and ensuring trials are delivered on time, within budget, and in compliance with regulations and company standards. The position offers an opportunity to manage trials from first-in-human single site to global Phase 3 studies within Jade’s immunology pipeline.
Responsibilities
- Support the development, maintenance, and execution of detailed study operational plans, timelines, enrollment projections, and tracking tools.
- Oversee vendor activities, including deliverables, performance, issue resolution, invoices, and scope tracking; support vendor selection and Scope of Work development.
- Maintain clinical trial budgets and forecasts; review invoices, track spend, identify variances, and escalate financial risks.
- Maintain study risk, issue, decision, and action logs; drive mitigation and resolution activities and escalate material risks with recommended options.
- Coordinate operational input into the development, review, and implementation of clinical documents.
- Oversee global or regional study start-up, site activation, enrollment, conduct, monitoring, closeout, and inspection-readiness activities.
- Support planning and conducting investigator meetings.
- Oversee monitoring activities, including reviewing monitoring reports for compliance and tracking/managing metrics.
- Build effective working relationships with clinical sites, investigators, CROs, vendors, and internal stakeholders.
- Review study performance metrics and operational data, identify trends or gaps, and implement corrective and preventive actions.
- Ensure clinical trial activities and documentation comply with the protocol, Good Clinical Practice, applicable regulations, contractual requirements, and company procedures.
- Support clinical supply, central laboratory, data management, safety, biostatistics, medical monitoring, and regulatory activities.
- Oversee the maintenance of a complete, accurate, and inspection-ready Trial Master File documentation and support audits, inspections, and quality oversight activities.
- Mentor Clinical Trial Associates and Clinical Trial Managers; contribute to Clinical Operations process improvements, and prepare study updates for governance and senior leadership.
Requirements
- Bachelors degree and 10+ years of related experience for Sr Clinical Trial Manager or 7+ years of related experience for Clinical Trial Manager.
- Trial management experience within a biopharmaceutical company; experience at a small startup is a plus.
- Demonstrated ability to manage complex clinical trial activities, timelines, vendors, budgets, risks, and cross-functional deliverables with appropriate independence and escalation.
- Experience supporting Phase 1 through Phase 3 clinical trials; global clinical trial experience is preferred.
- Immunology and/or rare disease clinical trial experience is preferred.
- Experience managing CROs and clinical vendors, including laboratories, RTSM, EDC, and ancillary clinical technology or applications.
- Strong working knowledge of FDA regulations, ICH guidelines, Good Clinical Practice, medical terminology, and clinical trial conduct.
- Working knowledge of clinical protocol implementation, regulatory submissions, Trial Master File requirements, and the overall drug development process.
- Experience mentoring or providing day-to-day guidance to junior team members is preferred.
- Excellent communication, organization, collaboration, problem-solving, and attention-to-detail skills.
- Ability to manage competing priorities.
Skills
- Clinical trial management
- Financial acumen
- Problem-solving
- Vendor oversight
- Budget management
- Risk management
- Cross-functional collaboration
- Communication
- Organization
- Attention to detail
Location
- Remote
Work Type
- Remote
- Full-time
Experience Level
- Senior
- Mid-level
Education Level
- Bachelors degree
Salary/Compensations
- $180,000 – $195,000 (Sr Clinical Trial Manager)
- $155,000 - $175,000 (Clinical Trial Manager)
About the Company
- Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for critical unmet needs in autoimmune diseases.
- The company's lead candidate, JADE101, targets the cytokine APRIL and is being evaluated for immunoglobulin A nephropathy.
- Jade’s pipeline also includes JADE201 (afucosylated anti-BAFF-R monoclonal antibody) and JADE301 (anti-IFN-β monoclonal antibody).
- Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount.
Equal Opportunity
- Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
- As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify.