[Hiring] Clinical Trials Senior Project Manager @Rochester Regional Health

Role Description

The primary role of the Clinical Trials (CT) Senior (Sr.) Project Manager is to liaise with ACM Global Central Laboratory clients, representing the laboratory aspects of conducting the clinical trial. The CT Sr. 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 15 to 30 protocols, depending on scope and complexity (managing above $6,000,000 in contract value).
• Run any protocol assigned, regardless of geographic coverage of site selection.
• Act as mentor and resource for junior members of department and teams.
• Review clinical protocols and assist with protocol set-up functions as required.
• Develop the Global Laboratory Specification Document, Investigator Manual, and protocol specific Global Work Practice Instructions.
• Participate and document Quality Audits and inspections of Clinical Trials.
• Evaluate and communicate monthly project metrics and analyze all activity related to the trial.
• Conduct investigator training sessions by telephone or at investigator meetings, involving overnight travel.
• Travel to client events (training, bid defenses, Investigator Meetings) and ACM international locations, requiring overnight travel.
• Assume full responsibility for study conduct on behalf of ACM, ensuring clients' goals and timelines are met.
• Responsible for On-Call coverage duties as assigned.
• Assume responsibility for regulatory required study documentation and comply with standard procedures.
• Develop protocol specific procedures as needed.
• Participate in the development of ACM Standard Operating Procedures as needed.
• Perform duties with a general working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations.
• Understand and follow company policies and procedures while maintaining patient and client confidentiality.

Qualifications

• 3 years project management experience
• 1 year experience in clinical trials, laboratory or healthcare setting

Preferred Qualifications

• Master’s Degree
• Excellent problem solving and communication skills

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.
• Cognitive and emotional demands are high due to extended concentration and independent decision-making.
• Occasional contact with infectious agents in healthcare environments.
• Some roles may require flexible hours, TB screening, or a valid driver’s license.

Pay Range

$100,000.00 - $125,000.00

Company Description

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any characteristic protected by federal, state, or local law.