Senior Clinical Trials Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the laboratory representative for ACM Global Central Laboratory clients involved in clinical trials.

• Function as the primary point of contact for clients, ensuring high levels of customer service and satisfaction.

• Oversee the management of assigned clinical trials from the initial setup through to maintenance and study closeout.

• Handle 15 to 30 protocols following the completion of the training period.

• Supervise regional Project Managers and coordinate necessary functions.

• Provide mentorship and support to junior members of the department and team.

• Review clinical protocols and assist in the 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.

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

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

• Identify and resolve issues to ensure that client objectives and timelines are achieved.

• Maintain regulatory study documentation and archive materials in accordance with regulations, ACM policies, and client contracts.

• Formulate protocol-specific procedures and contribute to ACM Standard Operating Procedures.

• Carry out on-call coverage duties as assigned.

⛳️ Requirements

• Minimum of 3 years of project management experience.

• At least 1 year of experience in clinical trials, laboratory, or healthcare settings.

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

• Proficiency in running protocols regardless of the geographic coverage of site selection.

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

• Willingness to travel overnight, including during weekends.

• Valid passport for international travel.

• Commitment to maintaining patient and client confidentiality.

• Master's Degree is preferred.

• Strong problem-solving and communication skills are preferred.

🏝️ Benefits

• Overnight travel opportunities for client events, investigator meetings, and ACM international locations.

• On-call coverage duties as assigned.