Clinical Trials Project Manager
New
R
Rochester Regional HealthClinical Research
Remote, United StatesFull-TimeMiddle
Salary80,000 - 100,000 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- 1+ years project management experience
- Required Skills
- Project ManagementGCP
Requirements
- 1+ years of project management experience.
- Bachelor’s degree (preferred).
- Experience working in a clinical trial, laboratory, or healthcare setting (preferred).
- Ability to travel for client events, training, and investigator meetings, including internationally.
- Valid passport for international travel requirements.
- Must be able to take on-call coverage duties as assigned.
- Working knowledge of FDA, NYSDOH, GCP, and ICH regulations.
- Excellent problem solving and communication skills.
Responsibilities
- Represent ACM as the primary client point of contact, ensuring high-level customer service and precise project delivery.
- Manage 10 to 25 protocols with responsibility for contract values over $3,000,000 and maintenance of 120+ billable PM hours per month.
- Develop and maintain key study documentation including Global Laboratory Specification Documents, Investigator Manuals, and Global Work Practice Instructions.
- Conduct investigator training sessions, potentially requiring overnight and weekend travel.
- Evaluate and analyze monthly project metrics and budgets to ensure study goals and timelines are met.
- Perform regulatory study documentation collection, maintenance, and archiving in accordance with FDA, NYSDOH, GCP, and ICH standards.
- Participate in quality audits and inspections as prescribed by departmental policy.
View Full Description & ApplyYou'll be redirected to the employer's site
