Location: Rochester, NY
Cap-Exempt H-1B Position — No lottery required
**Job Title:** Clinical Trials Project Manager **Department:** Study Management **Location:** Remote, United States **Hours Per Week:** 40 hours **Schedule:** Days, Monday – Friday **SUMMARY** The primary role of the Clinical Trials Project Manager is to liaise with ACM Global Central Laboratory clients, representing the laboratory aspects of conducting the clinical trial. In this role, the Clinical Trials Project Manager also liaises internally with all groups to assure ACM is conducting the trial according to the Global Laboratory Specification Document (GLSD) that is developed with the client. The Clinical Trials Project Manager is responsible for all aspects of their assigned clinical trials, from the set up stage, throughout the maintenance period and to study close out, facilitating and coordinating the required functions. **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