[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.
• Manage from 10 to 25 protocols after training, depending on scope and complexity.
• 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.
• Travel to client events 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.
• Responsible for On-Call coverage duties as assigned.
• Assumes responsibility for regulatory required study documentation and complies with standard procedures for collecting, maintaining, and archiving materials.
• Develops protocol specific procedures as needed.
• Performs duties with a general working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations.
• 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)

Physical Requirements

• Sedentary - primarily office-based with prolonged sitting (67–100% of the workday).
• Minimal physical effort and lifting limited to under 10 lbs.
• Fine motor skills necessary for computer work, writing, and telephone use.
• High cognitive and emotional demands due to extended concentration and independent decision-making.
• Occasional contact with infectious agents in administrative areas within healthcare environments.
• Some roles may require flexible hours, TB screening, or a valid driver’s license.
• Accommodations will be considered for any physical requirements reported by a prospective employee.

Pay Range

$80,000.00 - $100,000.00

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.