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Senior Clinical Trials Project Manager
Rochester Regional Health. Liaise with ACM Global Central Laboratory clients as the laboratory representative for clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, including protocol oversight, regulatory compliance, and client communication. Proficient in developing documentation and conducting training while ensuring project metrics and budgets are met.
Highest-signal resume keywords
Project Management ExperienceClinical Trials ExperienceRegulatory Knowledge (FDA, GCP, ICH)Protocol DevelopmentProblem Solving Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementProtocol SetupProject Budget EvaluationQuality Audits ParticipationDocumentation Maintenance
Soft Skills
Customer ServiceCommunication SkillsMentoringTroubleshooting
Certifications & Qualifications
Master's Degree Preferred
Industry Keywords
ACM Global Central LaboratoryHealthcare SettingPatient ConfidentialityStudy CloseoutInvestigator Training
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Liaise with ACM Global Central Laboratory clients as the laboratory representative for clinical trials
- Serve as the client's primary point of contact and maintain customer service and satisfaction
- Manage assigned clinical trials from setup through maintenance and study closeout
- Manage 15 to 30 protocols after the training period
- Oversee regional Project Managers and coordinate required functions
- Mentor and support junior department and team members
- 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 review project budgets
- Conduct investigator training sessions by telephone or at investigator meetings
- Troubleshoot and solve problems to ensure client goals and timelines are met
- Maintain regulatory study documentation and archive materials according to regulations, ACM policies, and client contractual clauses
- Develop protocol-specific procedures and contribute to ACM Standard Operating Procedures
- Perform on-call coverage duties as assigned
Requirements
What you’ll need- 3 years project management experience
- 1 year experience in clinical trials, laboratory or healthcare setting
- Ability to manage 15 to 30 protocols after training, depending on scope and complexity
- Ability to run protocols regardless of geographic coverage of site selection
- General working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations as they pertain to central laboratory functions
- Ability to travel overnight, including weekend travel
- Passport qualifications for international travel
- Ability to maintain patient and client confidentiality
- Master's Degree preferred
- Excellent problem solving and communication skills preferred
Benefits
Comp & perks- Overnight travel to client events, investigator meetings, and ACM international locations
- On-call coverage duties as assigned