Senior Clinical Trial Manager
Company: Warman O'Brien Agency
- Location: United States
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Senior Clinical Trial Manager – Transplantation & Study Start-Up
Location: United States (Remote)
We are seeking an experienced Senior Clinical Trial Manager with transplantation expertise and a strong background in study start-up to lead the operational delivery of clinical trials.
This role will take ownership of start-up planning and execution, driving site readiness and activation while supporting successful study delivery. Working closely with internal teams, investigators and external partners, you will ensure studies progress against agreed timelines, budgets and quality standards.
Key Responsibilities
- Lead clinical trial operations for assigned transplantation studies, with a particular focus on study start-up and site activation.
- Develop and manage start-up plans, timelines and milestones, identifying risks and implementing solutions to prevent delays.
- Oversee country and site feasibility, site selection and activation activities.
- Coordinate regulatory, ethics and essential document readiness with relevant teams.
- Partner with contracts and budgets teams to progress site negotiations and resolve activation barriers.
- Establish effective relationships with transplantation centres, investigators and study teams.
- Oversee CROs and vendors, ensuring clear accountability and delivery against agreed expectations.
- Coordinate cross-functional activities across Clinical Operations, Medical, Regulatory, Data Management and Safety.
- Monitor study progress, recruitment readiness, budgets and operational performance.
- Provide direction to CRAs and other study team members, supporting consistent execution and issue resolution.
- Maintain oversight of trial documentation and inspection readiness.
- Communicate study status, risks and decisions clearly to stakeholders.
Required Experience
- Demonstrated experience as a Clinical Trial Manager, Senior Clinical Trial Manager or equivalent.
- Direct experience managing clinical trials within transplantation.
- Strong experience leading study start-up, including feasibility, site selection and site activation.
- Proven ability to manage complex study timelines, competing priorities and operational challenges.
- Experience overseeing CROs, vendors and cross-functional study teams.
- Strong understanding of clinical trial processes, ICH-GCP and applicable regulatory requirements.
- Excellent communication, stakeholder management and problem-solving skills.
- Bachelor’s degree in life sciences, nursing or a related discipline, or equivalent relevant experience.
- Based in the United States.
Preferred Experience
- Experience working with US transplantation centres and specialist investigator networks.
- Previous CRA or clinical monitoring experience.
- Experience supporting studies from start-up through ongoing trial execution.
- Evidence of improving activation timelines and resolving complex site readiness issues.
Interested in finding out more? Please send across your CV.
