Clinical Trials Project Manager

This is a fully remote position, open to applicants in New York.

📋 Description

• Act as the laboratory representative for clinical trials, engaging with clients of ACM Global Central Laboratory.

• Collaborate internally with all departments to ensure adherence to the Global Laboratory Specification Document throughout trials.

• Oversee assigned clinical trials from their initiation through to maintenance and eventual closeout.

• Function as the primary contact for clients, ensuring their satisfaction is upheld.

• After completing training, manage between 10 to 25 protocols based on their complexity and scope.

• Assess clinical protocols and aid in their setup process.

• Create Global Laboratory Specification Documents, Investigator Manuals, and protocol-specific Global Work Practice Instructions.

• Engage in and document quality audits and inspections for clinical trials.

• Analyze and report monthly project metrics and trial activities, including a review of the monthly budget.

• Facilitate investigator training sessions via telephone or during investigator meetings.

• Travel to client events and ACM's international locations as necessary.

• Ensure that client objectives and timelines are achieved; troubleshoot and resolve issues as they arise.

• Provide designated on-call coverage as required.

• Maintain regulatory-required study documentation and archive materials in compliance with regulations, ACM policies, and client contractual obligations.

• Develop specific procedures for protocols as needed.

• Adhere to company policies and procedures while safeguarding patient and client confidentiality.

⛳️ Requirements

• A minimum of 1 year of project management experience is required.

• A Bachelor's Degree is preferred.

• Prior experience in a clinical trial, laboratory, or healthcare environment is desirable.

• A foundational understanding of FDA, NYSDOH, GCP, ICH, and relevant regulations related to central laboratory functions is beneficial.

• Willingness to travel overnight and frequently on weekends.

• Ability to attend client events and travel to ACM's international locations.

• Must possess valid passport qualifications.

• Capacity to undertake assigned on-call coverage responsibilities.

• Commitment to maintaining patient and client confidentiality.

• Ability to perform sedentary, office-based work involving prolonged sitting and minimal physical exertion.

• Strong problem-solving and communication skills are desirable.

🏝️ Benefits

• Opportunities for overnight travel and attendance at client events and ACM's international locations.

• Additional compensation components may be available.

• Potential for flexible working hours.

• Reasonable accommodations for reported physical requirements.