Remote Clinical Trials Project Lead

RRHS; United States; On-site; USD 80,000 - 100,000; Full time

Job summary

Rochester Regional Health is seeking a Clinical Trials Project Manager to coordinate laboratory aspects of clinical studies remotely in the United States. You will liaise with ACM Global Central Laboratory clients and internal groups to ensure trials align with the Global Laboratory Specification.

You will own all aspects from setup through maintenance to close-out, manage 10–25 protocols after training, oversee budgets and hours, perform protocol reviews, audits, and training, and travel as

Qualifications

• 1+ years project management experience.

Responsibilities

• Represents ACM as the client's primary point of contact, maintaining a high level of customer service and satisfaction.
• 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.

Skills

Project management

Education

Bachelor's Degree

Job description

Rochester Regional Health is seeking a Clinical Trials Project Manager to coordinate laboratory aspects of clinical studies remotely in the United States. You will liaise with ACM Global Central Laboratory clients and internal groups to ensure trials align with the Global Laboratory Specification.

You will own all aspects from setup through maintenance to close-out, manage 10–25 protocols after training, oversee budgets and hours, perform protocol reviews, audits, and training, and travel as