Clinical Trials Project Manager at Rochester… · ACM -…

Summary: Rochester Regional Health is a healthcare organization seeking a Clinical Trials Project Manager. The primary role is to liaise with clients and manage all aspects of clinical trials, ensuring compliance with specifications and maintaining high standards of service. Responsibilities: - Represents ACM as the client's primary point of contact, at all times maintaining a high level of customer service and satisfaction, displaying precision in delivery and flexibility in approach - After training period is complete, manage from 10 to 25 protocols, depending on scope and complexity (managing above $3,000,000 in contract value and maintaining more than 120 PM billable hours per month) - Review clinical protocols and assist with protocol set-up functions as required - Develops the Global Laboratory Specification Document, Investigator Manual, and protocol specific Global Work Practice Instructions - Participates and documents Quality Audits and inspections of Clinical Trials as prescribed by departmental policies and regulatory agencies - Evaluates and communicates monthly project metrics and analyses all activity related to the trial, including monthly budget review - Conducts investigator training sessions by telephone or at investigator meetings, which involves overnight travel, frequently on weekend days - Is able to travel to client events (training, bid defenses, Investigator Meetings) and ACM international locations, requiring overnight travel, as well as passport qualifications - Assumes full responsibility for study conduct on behalf of ACM, ensuring clients goals and timelines are met and performs troubleshooting and problem solving functions as the need arises - Responsible to take On-Call coverage duties as assigned - Assumes responsibility for regulatory required study documentation and complies with standard procedures for collecting, maintaining and then archiving the materials in accordance with regulations, ACM policies and client contractual clauses - Develops protocol specific procedures as needed - Performs duties with a general working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations, as pertains to central laboratory functions - Understands and follows company policies and procedures while always maintaining patient and client confidentiality, both inside and outside of the work place Required Qualifications: - 1+ years project management experience Preferred Qualifications: - Bachelor's Degree - Experience working in a clinical trial, laboratory or healthcare setting - Experience working with external clients in CRO, Clinical Trials, Pharma, Biotech industries - Excellent problem solving and communication skills Required Skills: Clinical trials, Global Laboratory Specification Document (GLSD), FDA regulations, NYSDOH regulations, Clinical Practice (GCP), International Council for Harmonisation (ICH) regulations, Project management