Clinical Trials Project Manager
About The Position
The Clinical Trials Project Manager serves as the primary client contact for the laboratory aspects of clinical trials and coordinates internally to ensure trials are conducted according to the Global Laboratory Specification Document developed with the client. The role is responsible for assigned trials from setup through maintenance and closeout, facilitating and coordinating the required functions. After training, the Project Manager manages 10 to 25 protocols depending on scope and complexity, with more than $3,000,000 in contract value and over 120 project-management billable hours per month. The position includes client and investigator training, travel to client events and international locations, on-call coverage, budget and project-metric reviews, and responsibility for study documentation and compliance with applicable regulations and company procedures.
Requirements
- At least 1 year of project management experience.
- Working knowledge of FDA, NYSDOH, GCP, ICH, and other pertinent regulations as they apply to central laboratory functions.
- Ability to travel overnight, including occasionally on weekends, and meet passport qualifications.
Nice To Haves
- Bachelor’s degree.
- Experience working in a clinical trial, laboratory, or healthcare setting.
- Excellent problem-solving and communication skills.
Responsibilities
- Serve as ACM’s primary client contact and maintain a high level of customer service and satisfaction.
- Manage assigned protocols, including their setup, maintenance, and closeout.
- Review clinical protocols and assist with protocol setup.
- Develop the Global Laboratory Specification Document, Investigator Manual, and protocol-specific Global Work Practice Instructions.
- Participate in and document quality audits and clinical-trial inspections as required by departmental policies and regulatory agencies.
- Evaluate and communicate monthly project metrics and review trial activity, including monthly budgets.
- Conduct investigator training by telephone or at investigator meetings.
- Travel to client events, including training, bid defenses, and Investigator Meetings, and to ACM international locations.
- Take responsibility for study conduct on ACM’s behalf, ensuring client goals and timelines are met and troubleshooting problems as needed.
- Provide on-call coverage as assigned.
- Manage regulatory-required study documentation, including collection, maintenance, and archiving in accordance with regulations, ACM policies, and client contractual clauses.
- Develop protocol-specific procedures as needed.
- Perform duties with working knowledge of applicable FDA, NYSDOH, GCP, ICH, and other regulations related to central laboratory functions.
- Follow company policies and procedures and maintain patient and client confidentiality.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
