About the Job
The Sr/Clinical Trial Manager will support the Director, Clinical Operations, who is the cross functional clinical trial leader, in the planning and operational execution of assigned clinical trials. This individual will coordinate day-to-day study activities across cross-functional partners, clinical sites, CROs, a...
Key Responsibilities
Support the development, maintenance, and execution on detailed study operational plans, timelines, enrollment projections, and tracking tools in alignment with program strategy and Director guidance
Responsible for vendor oversight activities, for assigned vendors, including deliverables, performance metrics, issue resolution, meeting governance, invoices, and scope tracking; supports vendor selection and Scope of Work development
Maintain clinical trial budgets and forecasts; review invoices, track committed and actual spend, identify variances, and escalate financial risks to the Director
Maintain study risk, issue, decision, and action logs; drives mitigation and resolution activities and promptly escalates material risks with recommended options
Coordinate operational input into the development, review, and implementation of clinical documents, including protocols, monitoring plans, informed consent forms, investigator brochures, pharmacy and laboratory manuals, and clinical study reports
Oversee global or regional study start-up, site activation, enrollment, conduct, monitoring, closeout, and inspection-readiness activities for assigned trials
Support planning and conducting investigator meetings in alignment with Director guidance
Responsible for monitoring oversight, inclusive of study specific templates and plans, reviewing monitoring reports for compliance to study protocols, regulations and ICF/GCP, tracking and managing monitoring report metrics.
Build effective working relationships with clinical sites, investigators, CROs, vendors, and internal stakeholders and serves as a key operational point of contact
Review study performance metrics and operational data, identifies trends or gaps, and implements corrective and preventive actions in partnership with the Director and cross-functional team
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 by coordinating operational requirements and timelines
Oversee the maintenance of a complete, accurate, and inspection-ready Trial Master File documentation and supports audits, inspections, and quality oversight activities
Mentor Clinical Trial Associates and Clinical Trial Managers; contributes to Clinical Operations process improvements, and prepare clear study updates for governance and senior leadership
Required Skills & Abilities
Bachelors and10+ years of related experience for Sr Clinical Trial Manager and 7+ years of related experience for the Clinical Trial Manager
Trial management 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, with the ability to manage competing priorities
