Clinical Trials Associate Project Manager
About The Position
The Clinical Trials Associate Project Manager serves as the liaison between ACM Global Central Laboratory and its clients, representing laboratory operations throughout clinical trials. The role also coordinates internally across teams to ensure trials are conducted according to the Global Laboratory Specification Document developed with the client. The associate project manager oversees assigned studies from setup through maintenance and closeout, facilitating and coordinating the functions needed for study delivery. With support from the Project Management Management Team and mentors, the role provides project management services, primarily for low-complexity studies.
Requirements
- At least 1 year of experience working in a clinical trials, laboratory, or health care setting.
- Excellent problem-solving and communication skills.
Nice To Haves
- Associate’s degree strongly preferred.
- Experience working in a clinical trial, laboratory, or healthcare setting.
Responsibilities
- Serve as ACM’s primary client contact and maintain strong customer service and satisfaction.
- Manage low-complexity studies, which may involve varying numbers of protocols.
- Review clinical protocols and assist with protocol setup.
- Develop or support the Global Laboratory Specification Document, Investigator Manual, and protocol-specific Global Work Practice Instructions.
- Participate in and support clinical trial quality audits and inspections in accordance with departmental policies and regulatory requirements.
- Evaluate and communicate monthly project metrics, analyze trial activity, and review monthly budgets.
- Take responsibility for study conduct on ACM’s behalf, ensuring client goals and timelines are met, and troubleshoot and solve problems as needed.
- Provide on-call coverage as assigned.
- Manage regulatory-required study documentation, including collection, maintenance, and archiving in accordance with regulations, company policies, and client contractual requirements.
- Develop protocol-specific procedures as needed.
- Perform duties with a general working knowledge of applicable FDA, NYSDOH, GCP, ICH, and other regulations relating to central laboratory functions.
- Follow company policies and procedures and protect patient and client confidentiality.
- Support Project Management administrative functions as needed.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
