Clinical Trials Sr. Project Manager

Rochester Regional Health; City of Rochester (NY); Remote; USD 100,000 - 125,000; Full time

Job summary

Rochester Regional Health seeks a Clinical Trials Senior Project Manager for a remote, United States–based position within Study Management. You will liaise with ACM Global Central Laboratory clients and internal teams to ensure trials align with the GLSD specification, from setup through closeout, coordinating required functions and timelines.

The role requires driving protocol outputs, mentoring junior staff, managing multiple protocols, and overseeing budgets and metrics, with travel for

Qualifications

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

Responsibilities

• Represents ACM as the client’s primary contact with excellent customer service and delivery.
• Manage 15 to 30 protocols after training, handling over $6,000,000 in contract value and >144 PM billable hours per month.
• Oversee output from all regional Project Managers and act as a senior mentor to junior staff.
• Review clinical protocols and assist with protocol setup functions as required.
• Develop the Global Laboratory Specification Document, Investigator Manual, and protocol-specific Global Work Practice Instructions.
• Participate in Quality Audits and inspections per policy and regulatory guidelines.
• Evaluate monthly project metrics and perform budget reviews.

Skills

Project management

Clinical trials

Communication

Budget management

Education

Master’s degree

Job description

Job Title: Clinical Trials Senior 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 (CT) Senior (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 CT Sr. Project Manager also liaises 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 CT 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.

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 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).
• To be able to run any protocol assigned to them, regardless of geographic coverage of site selection. To act as the Sr Project Manager, overseeing the output from all assigned regional Project Managers.
• Act as mentor and resource for junior members of department and teams.
• 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 analyzes 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 clients goals and timelines are met and performs troubleshooting and problem solving functions as the need arises.
• Responsible to take On-Call coverage duties as assigned.
• 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 in the development of ACM Standard Operating Procedures as needed.
• Performs duties with a general working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations, as pertains to central laboratory functions.
• Understands and follows company policies and procedures while always maintaining patient and client confidentiality, both inside and outside of the work place.

REQUIRED QUALIFICATIONS

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

PREFERRED QUALIFICATIONS

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

PHYSICAL REQUIREMENTS: Sedentary - Sedentary roles are primarily office-based and require prolonged sitting (67–100% of the workday) with minimal physical effort and lifting limited to under 10 lbs. Fine motor skills are necessary for computer work, writing, and telephone use, supported by clear visual and auditory ability. Cognitive and emotional demands are high due to extended concentration, frequent interruptions, independent decision-making, and information processing. Although physical exposure is low, administrative areas within healthcare environments may occasionally involve contact with infectious agents. Some roles may require flexible hours, TB screening, or a valid driver’s license.

PAY RANGE: $100,000.00 - $125,000.00