Clinical Trials Sr. Project Manager
About The Position
The Clinical Trials Senior Project Manager represents ACM Global Central Laboratory to clients and serves as the primary contact for the laboratory aspects of clinical trials. The role coordinates with internal groups and regional Project Managers to ensure trials are conducted according to the Global Laboratory Specification Document developed with the client. The Senior Project Manager oversees assigned trials from setup through maintenance and closeout, coordinating the functions required for each study. After training, the role manages approximately 15 to 30 protocols, depending on scope and complexity, with more than $6,000,000 in contract value and more than 144 Project Manager billable hours per month. The Senior Project Manager oversees assigned regional Project Managers, mentors junior colleagues, supports study documentation and quality activities, and helps ensure client goals and timelines are met. The position is remote in the United States, with a 40-hour workweek on a Monday–Friday day schedule. Travel for client events, investigator meetings, and ACM international locations may involve overnight stays and travel on weekends.
Requirements
- At least 3 years of project management experience.
- At least 1 year of experience in clinical trials, a laboratory, or a healthcare setting.
- Excellent problem-solving and communication skills.
- Ability to travel for client events and to ACM international locations, including overnight travel; passport qualifications are required.
- Ability to perform assigned on-call coverage duties.
Nice To Haves
- Master’s degree.
Responsibilities
- Serve as the client's primary point of contact and maintain customer service and satisfaction.
- Manage approximately 15 to 30 protocols after training, based on scope and complexity, and oversee assigned regional Project Managers.
- Run protocols regardless of the geographic coverage of site selection.
- Mentor and support junior department and team members.
- 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 clinical-trial quality audits and inspections as required by departmental policies and regulatory agencies.
- Evaluate and communicate monthly project metrics, analyze trial activity, and review monthly budgets.
- Conduct investigator training by telephone or at investigator meetings.
- Travel to client events and ACM international locations, including overnight travel.
- Take responsibility for study conduct on behalf of ACM, ensuring client goals and timelines are met, and troubleshoot and solve problems as needed.
- Perform assigned on-call coverage duties.
- Maintain regulatory-required study documentation and collect, maintain, and archive materials according to regulations, ACM policies, and client contractual clauses.
- Develop protocol-specific procedures as needed.
- Participate in developing ACM Standard Operating Procedures as needed.
- Perform duties with working knowledge of FDA, NYSDOH, GCP, ICH, and other regulations relevant 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
Senior
Education Level
No Education Listed
