Senior 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 while communicating with ACM Global Central Laboratory clients.

• Serve as the primary contact for clients.

• After training, manage between 15 to 30 clinical trial protocols, including those with contracts exceeding $6,000,000.

• Supervise regional Project Managers and the outputs of assigned clinical trials.

• Provide mentorship to junior team members and department staff.

• Review 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 of clinical trials.

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

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

• Travel to client events and ACM international sites.

• Ensure the study conduct aligns with client objectives and timelines; troubleshoot and resolve issues as they arise.

• Carry out assigned on-call coverage responsibilities.

• Manage regulatory study documentation and archive materials in accordance with regulations, ACM policies, and client contract stipulations.

• Develop procedures specific to protocols and contribute to ACM Standard Operating Procedures.

⛳️ Requirements

• At least 3 years of experience in project management.

• Minimum of 1 year of experience in clinical trials, laboratory, or healthcare environments.

• Familiarity with FDA, NYSDOH, GCP, ICH, and other relevant regulations pertaining to central laboratory operations.

• Capability to manage 15 to 30 protocols post-training, based on scope and complexity.

• Ability to operate protocols irrespective of the geographical location of site selection.

• Willingness to travel overnight for client events and ACM international locations.

• Valid passport is required.

• Commitment to maintaining patient and client confidentiality.

• A Master’s Degree is preferred.

• Strong problem-solving and communication skills are preferred.

🏝️ Benefits

• Overnight travel for investigator training sessions, client events, and ACM international locations.

• Responsibilities for on-call coverage.

• Flexible working hours may be necessary.

• Consideration for accommodations based on reported physical requirements.