Senior Clinical Trials Project Manager

Job not on LinkedIn

🔥 1 minute ago

🗽 New York – Remote

🗽 New York – Remote

💵 $100k - $125k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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ACM Global Laboratories

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

ACM Global Laboratories is a leading provider of clinical trial testing services, supporting clinical trials globally in over 65 countries. The company offers a range of bioanalytical services, including small and large molecule analysis, biomarker analysis, and various laboratory testing solutions such as routine safety testing, flow cytometry, and advanced sample tracking. ACM Global Laboratories is recognized for its expertise in bioanalysis and toxicology services, ensuring high sensitivity and accuracy in drug and metabolite measurements across diverse biological samples. The company is dedicated to delivering actionable clinical insights and reliable toxicology services to healthcare providers, partnering with clinical trials to optimize development projects through state-of-the-art laboratory services, specimen management, and global logistics.

📋 Description

• Liaise with ACM Global Central Laboratory clients as the laboratory representative for clinical trials • Serve as the client’s primary point of contact • Manage 15 to 30 clinical trial protocols after training, including protocols exceeding $6,000,000 in contract value • Oversee regional Project Managers and assigned clinical trial outputs • Mentor junior department and team members • Review clinical protocols and assist with protocol setup • Develop Global Laboratory Specification Documents, Investigator Manuals, and protocol-specific Global Work Practice Instructions • Participate in and document clinical trial quality audits and inspections • Evaluate and communicate monthly project metrics and review project budgets • Conduct investigator training sessions by telephone or at investigator meetings • Travel to client events and ACM international locations • Ensure study conduct, client goals, and timelines are met; troubleshoot and solve problems • Perform assigned on-call coverage duties • Manage regulatory study documentation and archive materials according to regulations, ACM policies, and client contractual clauses • Develop protocol-specific procedures and contribute to ACM Standard Operating Procedures

🎯 Requirements

• 3 years project management experience • 1 year experience in clinical trials, laboratory or healthcare setting • Working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations as related to central laboratory functions • Ability to manage 15 to 30 protocols after training, depending on scope and complexity • Ability to run protocols regardless of geographic coverage of site selection • Ability to travel overnight to client events and ACM international locations • Passport qualifications • Ability to maintain patient and client confidentiality • Master’s Degree preferred • Excellent problem solving and communication skills preferred

🏖️ Benefits

• Overnight travel for investigator training sessions, client events, and ACM international locations • On-call coverage duties • Flexible hours may be required • Accommodations considered for reported physical requirements