Senior Clinical Trial Manager
Company: SoTalent Agency
- Location: United States
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Senior Clinical Trial Manager – Global Clinical Operations
Location: Philadelphia, PA, US
Employment Type: Full-time
Work Model: Remote
Salary: $145,600–$218,400/year
Overview
Senior Clinical Trial Manager responsible for leading global Phase I–IV clinical trials from planning through closeout. The role oversees study strategy, cross-functional execution, vendors, budgets, timelines, documentation, risk management and GCP compliance while providing operational leadership across global clinical teams.
Key Responsibilities
- Lead planning, implementation and execution of global, multi-center Phase I–IV clinical trials.
- Develop trial strategies, timelines, budgets, recruitment plans and risk mitigation plans.
- Coordinate cross-functional study teams and lead trial-related meetings and working groups.
- Provide operational oversight of external service providers and clinical vendors.
- Manage vendor performance, financial spend, timelines and contractual deliverables.
- Oversee Trial Master File (TMF) activities and essential trial documentation.
- Review and approve protocols, informed consent forms, monitoring plans and Clinical Study Reports.
- Support feasibility, study start-up, investigator selection and patient recruitment strategies.
- Lead Investigator Meeting planning and delivery.
- Identify and manage operational risks, issues and contingencies.
- Provide study updates, risks and recommendations to senior leadership.
- Serve as a clinical operations subject matter expert during audits and regulatory inspections.
- Ensure trial activities comply with ICH-GCP, SOPs, regulatory requirements and study protocols.
- Coordinate clinical supplies and investigational medicinal product shipment activities.
- Support monitoring report review, data query processes and trial management systems.
- Contribute to Clinical Operations and Global Clinical Development Operations initiatives.
- Mentor and coach Clinical Research Associates, Global Study Managers and Global Study Associates.
- Lead high-performing clinical trial teams and support resolution of complex study issues.
Requirements
- 7+ years of clinical research experience, including global clinical trial management.
- At least 3 years in clinical operations leadership.
- Proven experience managing global, multi-center clinical trials.
- Strong knowledge of clinical trial processes, ICH-GCP and regulatory requirements.
- Experience with study start-up and regulatory planning.
- Experience with CTMS, TMF and other clinical trial management systems.
- Strong vendor, budget, timeline and risk management experience.
- Excellent project management and organisational skills.
- Strong stakeholder management, communication and influencing skills.
- Bachelor’s degree in Life Sciences, Healthcare or related field, or equivalent experience.
- Advanced degree preferred.
- Proficiency in Microsoft Office.
