Clinical Trials Project Manager

Rochester Regional Health • United States, United States • 1d ago

Job Title: Clinical Trials Project ManagerDepartment: Study Management Location: Remote, United StatesHours Per Week: 40 hoursSchedule: 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 (GLSD) 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 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.

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

1+ years project management experience

PREFERRED QUALIFICATIONS

Bachelor's Degree

Experience working in a clinical trial, laboratory or healthcare setting

Experience working with external clients in CRO, Clinical Trials, Pharma, Biotech industries

Excellent problem solving and communication skills

EDUCATION:

LICENSES / CERTIFICATIONS:

PHYSICAL REQUIREMENTS:

S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

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

CITY:

Rochester

POSTAL CODE:

14624

The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

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.

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