Clinical Trials Associate Project Manager

Rochester Regional Health; City of Rochester (NY); A distancia; USD 65.000 - 85.000; Jornada completa

Descripción de la vacante

ACM Global Laboratories is seeking a Clinical Trials Associate Project Manager to liaise with clients and internal teams, ensuring trials adhere to the Global Laboratory Specification. Responsible from setup through close-out, coordinating required functions to meet client goals and timelines.

The role requires 1 year in clinical trials or healthcare, strong problem solving and communication skills, and a preferably Associate's degree.

Formación

• Minimum 1 year of experience working in a clinical trials, laboratory or health care setting.
• Associate's degree strongly preferred.
• Excellent problem solving and communication skills.

Responsabilidades

• Represent ACM Global Laboratories as the client's primary point of contact, maintaining a high level of customer service and satisfaction.
• Manage low complexity studies per the ACM study assessment tool with varying protocols.
• Review clinical protocols and assist with protocol set-up functions.
• Develop and/or support the Global Laboratory Specification Document, Investigator Manual, and protocol-specific World Practice Instructions.
• Participate in and support Quality Audits and inspections of Clinical Trials as prescribed by policies and regulators.
• Evaluate and communicate monthly project metrics and analyses including budget reviews.
• Assume responsibility for study conduct and regulatory documentation; ensure timelines and client goals are met.
• Take On-Call coverage duties as assigned.
• Follow FDA, NYSDOH, GCP, ICH and related regulations; maintain patient and client confidentiality.
• Provide support for Project Management administrative functions.
• Perform other duties as assigned.

Conocimientos

Clinical trials experience

Communication skills

Educación

Associate's degree

Descripción del empleo

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

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: $65,000.00 - $85,000.00