Remote Clinical Trials Project Manager — Lead Multi-Protocol Studies

ACM Global Laboratories, Inc.; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

ACM Global Laboratories, Inc. seeks a Clinical Trials Project Manager to liaise with clients and internal teams, ensuring trials align with the Global Laboratory Specification Document developed with the client.

This remote, United States-based role oversees trial setup to closeout, manages multiple protocols, oversees budgets and metrics, and requires travel for investigator meetings as needed.

Qualifications

• 1+ years project management experience.
• Bachelor’s Degree or higher preferred.
• Experience working in a clinical trial, laboratory or healthcare setting preferred.

Responsibilities

• Represents ACM as the client's primary point of contact, maintaining high level of customer service and satisfaction while delivering with precision and flexibility.
• After training, manage from 10 to 25 protocols, depending on scope and complexity (contract value above $3,000,000 and >120 PM billable hours/month).
• Review clinical protocols and assist with protocol set-up functions as required.
• Develop the Global Laboratory Specification Document, Investigator Manual, and protocol-specific Global Work Practice Instructions.
• Participate in and document Quality Audits and inspections of Clinical Trials as prescribed by regulatory agencies.
• Evaluate and communicate monthly project metrics and analyses, including monthly budget review.
• Conduct investigator training sessions by telephone or at investigator meetings, involving overnight travel.
• Travel to client events and ACM international locations, requiring overnight travel and passport qualifications.
• Assume full responsibility for study conduct on behalf of ACM, ensuring client goals and timelines are met and perform troubleshooting as needed.
• Take On-Call coverage duties as assigned.
• Maintain regulatory study documentation and comply with procedures for collection, maintenance, and archiving.
• Develop protocol-specific procedures as needed.
• Maintain knowledge of FDA, NYSDOH, GCP, ICH and related regulations as pertains to central laboratory functions.
• Follow company policies and confidentiality requirements.

Skills

Project management

Education

Bachelor’s Degree

Job description

ACM Global Laboratories, Inc. seeks a Clinical Trials Project Manager to liaise with clients and internal teams, ensuring trials align with the Global Laboratory Specification Document developed with the client.

This remote, United States-based role oversees trial setup to closeout, manages multiple protocols, oversees budgets and metrics, and requires travel for investigator meetings as needed.