Clinical Trials Project Manager
Posted 1hrs ago
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Job Description
Clinical Trials Project Manager coordinating central-laboratory clinical studies for Rochester Regional Health. Managing protocols, regulatory documentation, client communication, budgets, training, and study closeout.
Responsibilities:
- Liaise with ACM Global Central Laboratory clients as the laboratory representative for clinical trials
- Liaise internally with all groups to ensure trials follow the Global Laboratory Specification Document
- Manage assigned clinical trials from setup through maintenance and study closeout
- Serve as the client's primary point of contact and maintain customer satisfaction
- After training, manage 10 to 25 protocols depending on scope and complexity
- Review clinical protocols and assist with protocol setup
- Develop Global Laboratory Specification Documents, Investigator Manuals, and protocol-specific Global Work Practice Instructions
- Participate in and document clinical trial quality audits and inspections
- Evaluate and communicate monthly project metrics and analyze trial activity, including monthly budget review
- Conduct investigator training sessions by telephone or at investigator meetings
- Travel to client events and ACM international locations as required
- Ensure client goals and timelines are met; troubleshoot and solve problems
- Provide assigned on-call coverage
- Maintain regulatory-required study documentation and archive materials according to regulations, ACM policies, and client contractual clauses
- Develop protocol-specific procedures as needed
- Follow company policies and procedures while maintaining patient and client confidentiality
Requirements:
- 1+ years project management experience
- Bachelor's Degree is preferred
- Experience working in a clinical trial, laboratory or healthcare setting is preferred
- General working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations as they pertain to central laboratory functions
- Ability to travel overnight, frequently on weekend days
- Ability to travel to client events and ACM international locations
- Passport qualifications
- Ability to take assigned on-call coverage duties
- Ability to maintain patient and client confidentiality
- Ability to perform sedentary, primarily office-based work with prolonged sitting and minimal physical effort
- Excellent problem solving and communication skills are preferred
Benefits:
- Overnight travel and travel to client events and ACM international locations
- Additional pay components may be available
- Potential flexible hours
- Reasonable accommodations for reported physical requirements


















