[Hiring] Clinical Trials Project Manager @Rochester Regional Health

Role Description

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 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, maintaining a high level of customer service and satisfaction.
• Manages from 10 to 25 protocols after training, depending on scope and complexity (managing above $3,000,000 in contract value and maintaining more than 120 PM billable hours per month).
• Reviews clinical protocols and assists 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.
• Travels to client events (training, bid defenses, Investigator Meetings) and ACM international locations, requiring overnight travel and 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 needed.
• Takes On-Call coverage duties as assigned.
• Assumes responsibility for regulatory required study documentation and complies with standard procedures for collecting, maintaining, and archiving 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 they pertain to central laboratory functions.
• Understands and follows company policies and procedures while maintaining patient and client confidentiality.

Qualifications

• 1+ years project management experience

Requirements

• Bachelor’s Degree (preferred)
• Experience working in a clinical trial, laboratory, or healthcare setting (preferred)
• Excellent problem-solving and communication skills (preferred)

Benefits

• Pay Range: $80,000.00 - $100,000.00
• The posted pay range is a good faith representation of potential base pay for this position.
• Individual annual salaries/hourly rates could vary based on position details and FTE.
• Pay is determined by considering factors including experience, relevant qualifications, specialty, internal equity, locations, and contracts.

Company Description

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.