Lead day-to-day management of clinical studies to ensure delivery against timelines, budget, and quality expectations
Drive study milestones and proactively identify and mitigate risks
Oversee CROs, laboratories, and vendors to ensure performance aligns with scope, timelines, and budget
Manage vendor relationships, including scope changes, issue resolution, and ongoing performance oversight
Partner with internal stakeholders across Clinical, Regulatory, Data Management, and other functions
Serve as a central operational lead to ensure alignment and efficient study execution
Contribute to study planning, including timelines, resource plans, budgets, and risk management strategies
Provide operational input into protocol development, feasibility, and study design
Act as the primary sponsor contact for study sites
Oversee site startup and ongoing site management activities
Ensure proper sample handling, data flow, and protocol adherence
Ensure compliance with ICH/GCP, FDA regulations, and company SOPs
Maintain inspection readiness and support audits and regulatory inspections
Ensure completeness and integrity of the Trial Master File (TMF)
Author and review study plans, operational documents, and training materials
Communicate study status, risks, and mitigation plans to stakeholders
Contribute to process improvements and operational excellence initiatives
(Sr. CTM) Lead cross-study or departmental initiatives

Bachelor’s degree in life sciences or a related field; advanced degree preferred
Clinical Trial Manager: minimum 7 years of clinical research experience; 4 years with advanced degree
Senior Clinical Trial Manager: experience leading complex or global studies, worked on a clinical study from concept to database lock
Strong knowledge of ICH/GCP, FDA regulations, and clinical trial operations
Experience managing CROs and other external vendors
Proven ability to manage timelines, budgets, and multiple priorities
Excellent communication, problem-solving, and leadership skills
Demonstrated leadership skills
Ability to work effectively in a fast-paced, collaborative environment
Ability to travel to sites as needed, including international travel
Ability to work Eastern Time Zone and travel to New York HQ quarterly

Clinical Trial Manager – Senior

Key skills