Senior Clinical Trials Project Manager

Job not on LinkedIn

🔥 9 minutes ago

🇺🇸 United States – Remote

💵 $100k - $125k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Rochester Regional Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

📚 Education

Healthcare • Healthcare Insurance • Education

Rochester Regional Health is an integrated health services organization serving the people of Western New York. It operates multiple hospitals and healthcare facilities, providing a wide range of healthcare services, including emergency care, primary care, specialty clinics, and urgent care. The organization is committed to medical education and research, offering training programs, residencies, and clinical trials. Rochester Regional Health focuses on comprehensive care with emphasis on treating patients respectfully and meeting their diverse medical needs across all stages of life.

📋 Description

• Liaise with ACM Global Central Laboratory clients as the laboratory representative for clinical trials • Serve as the client's primary point of contact and maintain customer service and satisfaction • Manage assigned clinical trials from setup through maintenance and study closeout • Manage 15 to 30 protocols after the training period • Oversee regional Project Managers and coordinate required functions • Mentor and support 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 • Troubleshoot and solve problems to ensure client goals and timelines are met • Maintain 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 • Perform on-call coverage duties as assigned

🎯 Requirements

• 3 years project management experience • 1 year experience in clinical trials, laboratory or healthcare setting • 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 • General working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations as they pertain to central laboratory functions • Ability to travel overnight, including weekend travel • Passport qualifications for international travel • Ability to maintain patient and client confidentiality • Master's Degree preferred • Excellent problem solving and communication skills preferred

🏖️ Benefits

• Overnight travel to client events, investigator meetings, and ACM international locations • On-call coverage duties as assigned