Job Title: Clinical Trials Associate 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) Associate 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 Associate 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 CT Associate 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

• With the support of the PM Management Team and Project Management mentors the CT Associate Project Manager is responsible for providing a Project Management service within ACM Global Laboratories including but not limited to:
• Represent 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.
• Manage low complexity studies per the ACM study assessment tool with a varying number of protocols.
• Review clinical protocols and assist with protocol set-up functions as required.
• Develop and/or support the Global Laboratory Specification Document, Investigator Manual, and protocol specific Global Work Practice Instructions.
• Participate in and support Quality Audits and inspections of Clinical Trials as prescribed by departmental policies and regulatory agencies.
• Evaluate and communicate monthly project metrics and analyses all activity related to the trial, including monthly budget review.
• Assume full responsibility for study conduct on behalf of ACM, ensuring client’s goals and timelines are met and perform troubleshooting and problem solving functions as the need arises.
• Responsible to take On-Call coverage duties as assigned.
• Assume responsibility for regulatory required study documentation and comply with standard procedures for collecting, maintaining and then archiving the materials in accordance with regulations, ACM policies and client contractual clauses.
• Develop protocol specific procedures as needed.
• Perform duties with a general working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations, as pertains to central laboratory functions.
• Understand and follow company policies and procedures while always maintaining patient and client confidentiality, both inside and outside of the work place.
• Provide support for Project Management administrative functions as needed.
• Perform other duties as assigned.

REQUIRED QUALIFICATIONS

• Minimum of 1 year of experience working in a clinical trials, laboratory or health care setting required

PREFERRED QUALIFICATIONS

• Associate’s degree strongly preferred
• Experience working in a clinical trial, laboratory or healthcare setting
• Excellent problem solving and communication skills

EDUCATION:

LICENSES / CERTIFICATIONS:

PHYSICAL REQUIREMENTS:

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:

CITY:

POSTAL CODE:

The posted pay range is a good faith representation of potential base pay for this position. It may be modified in the future and eligible for additional pay components. Individual annual salaries/hourly rates could vary based on position details and FTE. Pay is determined by considering factors including, but not limited to, experience, relevant qualifications, specialty, internal equity, locations, 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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