Clinical Trials Associate Project Manager

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $65k - $85k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👷‍♀️ Project Manager

🚫👨‍🎓 No degree required

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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 and represent laboratory aspects of clinical trials • Coordinate assigned clinical trials from setup through maintenance and study closeout • Serve as ACM’s primary client point of contact and maintain customer satisfaction • Manage low-complexity studies and varying numbers of protocols • Review clinical protocols and assist with protocol setup • Develop or support Global Laboratory Specification Documents, Investigator Manuals, and protocol-specific Global Work Practice Instructions • Participate in and support clinical-trial quality audits and inspections • Evaluate and communicate monthly project metrics and analyze trial activity, including monthly budget review • Ensure study goals and timelines are met; troubleshoot and resolve problems • Provide assigned on-call coverage • Manage regulatory-required study documentation in accordance with regulations, company policies, and client contracts • Develop protocol-specific procedures as needed • Provide project-management administrative support and perform other assigned duties

🎯 Requirements

• Minimum of 1 year of experience working in a clinical trials, laboratory or health care setting required • General working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations as pertains to central laboratory functions • Ability to manage low complexity studies with varying numbers of protocols • Experience reviewing clinical protocols and supporting protocol set-up functions • Ability to develop or support Global Laboratory Specification Documents, Investigator Manuals, and protocol-specific Global Work Practice Instructions • Ability to support quality audits and inspections of clinical trials • Knowledge of regulatory study documentation, collection, maintenance, and archiving requirements • Excellent problem-solving and communication skills • Ability to maintain patient and client confidentiality • Associate’s degree strongly preferred