Senior Project Manager | Clinical Trials
The primary role of the Sr Project Manager is to liaise with ACM Global Central Laboratory clients, representing the laboratory aspects of conducting the clinical trial. In this role, the Sr Project Manager also liaise internally, as well as with the regional Project Managers, 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 Sr Project Manager is responsible for all aspects of the their assigned clinical trials, from the set up stage, throughout the maintenance period and to study close out, facilitating and coordinating the required functions.
STATUS: Full Time
LOCATION: ACM Global Laboratories | Rochester Technology Park
DEPARTMENT: Clinical Trials Study Management
- Bachelor’s degree required, or 5 years relevant experience and must be matriculated. A degree in a health care or scientific concentration is preferred.
- Two years of Health Care related experience OR a minimum of twelve months of project management experience required.
- Excellent verbal and written communication skills required.
- Customer service experience required.
- Strong computer skills required; familiarity with relational databases and reporting tool strongly preferred.
- Client Management. 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. 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 client's goals and timelines are met and performs troubleshooting and problem solving functions as the need arises.
- Project Management. After training period is complete, manage from 15 to 30 protocols, depending on scope and complexity (managing above $6,000,000 in contract value and maintaining more than 144 PM billable hours per month). Run any protocol assigned, regardless of geographic coverage of site selection. To act as the Sr Project Manager, overseeing the output from all assigned regional Project Managers. 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. 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. Participates and documents Quality Audits and inspections of Clinical Trials as prescribed by departmental policies and regulatory agencies.
- Leadership. Act as mentor and resource for junior members of department and teams. Responsible to take On-Call coverage duties as assigned. Participates in the development of ACM Standard Operating Procedures as needed. Participate in training new Project Managers.