[Remote] Clinical Trials Project Manager

Note: The job is a remote job and is open to candidates in USA. Rochester Regional Health is a healthcare organization seeking a Clinical Trials Project Manager to liaise with clients and manage clinical trials. The role involves coordinating trial activities, ensuring compliance with specifications, and maintaining high levels of customer service throughout the trial process.ResponsibilitiesRepresents 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 approachAfter 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 requiredDevelops the Global Laboratory Specification Document, Investigator Manual, and protocol specific Global Work Practice InstructionsParticipates and documents Quality Audits and inspections of Clinical Trials as prescribed by departmental policies and regulatory agenciesEvaluates and communicates monthly project metrics and analyses all activity related to the trial, including monthly budget reviewConducts investigator training sessions by telephone or at investigator meetings, which involves overnight travel, frequently on weekend daysIs able to travel to client events (training, bid defenses, Investigator Meetings) and ACM international locations, requiring overnight travel, as well as passport qualificationsAssumes 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 arisesResponsible to take On-Call coverage duties as assignedAssumes 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 clausesDevelops protocol specific procedures as neededPerforms duties with a general working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations, as pertains to central laboratory functionsUnderstands and follows company policies and procedures while always maintaining patient and client confidentiality, both inside and outside of the work placeSkills1+ years project management experienceBachelor's DegreeExperience working in a clinical trial, laboratory or healthcare settingExcellent problem solving and communication skillsCompany OverviewRochester Regional Health provides integrated health services. It was founded in 1847, and is headquartered in Rochester, New York, USA, with a workforce of 10001+ employees. Its website is https://www.rochesterregional.org.



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