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Senior Clinical Trial Manager
Jade Biosciences. Support the Director, Clinical Operations, in planning and operational execution of assigned clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing complex clinical trial activities, including vendor management, budget oversight, and compliance with regulatory standards. Proficient in coordinating cross-functional teams and maintaining an inspection-ready Trial Master File throughout the drug development process.
Highest-signal resume keywords
Clinical Trial ManagementVendor ManagementBudget OversightFDA RegulationsGood Clinical Practice
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementBudget ManagementRisk ManagementProtocol ImplementationRegulatory SubmissionsTrial Master File MaintenancePhase 1-3 Clinical TrialsCRO ManagementClinical Technology ApplicationsMedical Terminology
Soft Skills
CommunicationOrganizationCollaborationProblem-SolvingAttention to Detail
Tools & Technologies
EDCRTSMClinical Trial Management SystemsData Management ToolsBiostatistics Software
Industry Keywords
BiopharmaceuticalGood Clinical PracticeICH GuidelinesClinical OperationsDrug Development Process
About the role
Key responsibilities & impact- Support the Director, Clinical Operations, in planning and operational execution of assigned clinical trials
- Coordinate day-to-day study activities across cross-functional partners, clinical sites, CROs, and vendors
- Maintain study plans, timelines, budgets, risks, and key documentation
- Oversee vendor deliverables, performance metrics, issue resolution, meeting governance, invoices, and scope tracking
- Maintain clinical trial budgets and forecasts; review invoices, track spend, identify variances, and escalate financial risks
- Maintain risk, issue, decision, and action logs; drive mitigation and resolution activities
- Coordinate operational input into protocols, monitoring plans, informed consent forms, investigator brochures, manuals, and clinical study reports
- Oversee study start-up, site activation, enrollment, conduct, monitoring, closeout, and inspection-readiness activities
- Support investigator meetings and monitoring oversight
- Build relationships with clinical sites, investigators, CROs, vendors, and internal stakeholders
- Review study performance metrics and implement corrective and preventive actions
- Ensure trial activities and documentation comply with protocols, Good Clinical Practice, regulations, contracts, and company procedures
- Coordinate operational requirements and timelines across clinical supply, laboratories, data management, safety, biostatistics, medical monitoring, and regulatory activities
- Maintain an accurate, inspection-ready Trial Master File and support audits, inspections, and quality oversight
- Mentor Clinical Trial Associates and Clinical Trial Managers, contribute to process improvements, and prepare study updates for governance and senior leadership
Requirements
What you’ll need- Bachelor’s degree and 10+ years of related experience for Senior Clinical Trial Manager, or 7+ years of related experience for Clinical Trial Manager
- Trial management experience within a biopharmaceutical company
- 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
- 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
- Excellent communication, organization, collaboration, problem-solving, and attention-to-detail skills, with the ability to manage competing priorities
- Authorization to work in the United States verified through Form I-9 and E-Verify
Benefits
Comp & perks- Remote work
- Periodic travel to team and company events
- Equal Opportunity employment