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 ACM Global Central Laboratory clients.

• Coordinate internally to guarantee adherence to the Global Laboratory Specification Document throughout trials.

• Oversee assigned clinical trials from initiation to maintenance and final study closeout.

• Serve as the primary contact for the client.

• Manage between 10 to 25 protocols following the completion of the training period.

• Analyze clinical protocols and assist in their setup.

• 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.

• Assess and communicate monthly project metrics while reviewing project budgets.

• Conduct training sessions for investigators via telephone or during investigator meetings.

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

• Ensure that client objectives and timelines are achieved; troubleshoot and resolve any arising issues.

• Perform designated on-call coverage responsibilities.

• Manage regulatory study documentation, including collection, maintenance, and archiving.

• Develop protocol-specific procedures as required.

• Adhere to relevant company policies, procedures, and regulatory requirements.

⛳️ Requirements

• A minimum of 1 year of project management experience.

• Experience in a clinical trial, laboratory, or healthcare environment.

• Strong problem-solving and communication skills.

• Fundamental understanding of FDA, NYSDOH, GCP, ICH, and other relevant regulations related to central laboratory operations.

• Willingness to travel overnight, including frequent weekend trips.

• Valid passport for international travel.

• Capability to handle assigned on-call coverage duties.

• Ability to maintain confidentiality regarding patients and clients.

• Capacity to perform sedentary, office-based tasks with prolonged sitting and minimal lifting.

• A Bachelor's Degree is preferred, but not mandatory.

🏝️ Benefits

• Full-time employment opportunity.

• 40 hours per week with a Monday–Friday daytime schedule.

• Additional pay components may be available.

• Opportunities for travel to client events and ACM's international locations.

• Equal opportunity employer.