Clinical Trials Project Manager

Clinical Trials Project Manager role at ACM Global Laboratories

Overview

The primary role of the Clinical Trials Project Manager is to liaise with ACM Global Laboratory clients, representing the laboratory aspects of conducting the clinical trial. The Clinical Trials Project Manager 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

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Project Management, Quality Assurance, and Administrative

Industries

• Biotechnology Research, Pharmaceutical Manufacturing, and Research Services