Clinical Trials Project Manager

ACM Global Laboratories, Inc.; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

ACM Global Laboratories, Inc. seeks a Clinical Trials Project Manager to liaise with clients and internal teams, ensuring trials align with the Global Laboratory Specification Document developed with the client.

This remote, United States-based role oversees trial setup to closeout, manages multiple protocols, oversees budgets and metrics, and requires travel for investigator meetings as needed.

Qualifications

• 1+ years project management experience.
• Bachelor’s Degree or higher preferred.
• Experience working in a clinical trial, laboratory or healthcare setting preferred.

Responsibilities

• Represents ACM as the client's primary point of contact, maintaining high level of customer service and satisfaction while delivering with precision and flexibility.
• After training, manage from 10 to 25 protocols, depending on scope and complexity (contract value above $3,000,000 and >120 PM billable hours/month).
• 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 in and document Quality Audits and inspections of Clinical Trials as prescribed by regulatory agencies.
• Evaluate and communicate monthly project metrics and analyses, including monthly budget review.
• Conduct investigator training sessions by telephone or at investigator meetings, involving overnight travel.
• Travel to client events and ACM international locations, requiring overnight travel and passport qualifications.
• Assume full responsibility for study conduct on behalf of ACM, ensuring client goals and timelines are met and perform troubleshooting as needed.
• Take On-Call coverage duties as assigned.
• Maintain regulatory study documentation and comply with procedures for collection, maintenance, and archiving.
• Develop protocol-specific procedures as needed.
• Maintain knowledge of FDA, NYSDOH, GCP, ICH and related regulations as pertains to central laboratory functions.
• Follow company policies and confidentiality requirements.

Skills

Project management

Education

Bachelor’s Degree

Job description

Job Title: Clinical Trials 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 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, 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 10 to 25 protocols, depending on scope and complexity (managing above $3,000,000 in contract value and maintaining more than 120 PM billable hours per month).


• 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, 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.


• 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.


• 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 workplace.

REQUIRED QUALIFICATIONS

• 1+ years project management experience

PREFERRED QUALIFICATIONS

• Bachelor’s Degree


• Experience working in a clinical trial, laboratory or healthcare setting


• 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.

For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

PAY RANGE:

$80,000.00 - $100,000.00

POSTAL CODE:

14624

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.