Note: The job is a remote job and is open to candidates in USA. Randstad Digital Americas is recruiting for a clinical research project manager to lead investigator-initiated trials from planning through oversight. The role coordinates study teams, clinical documentation and regulatory submissions while maintaining data quality and audit-ready files.
Responsibilities
- Lead end-to-end project management and timeline oversight for assigned investigator-initiated trials (IITs)
- Serve as the primary point of contact for investigators, regulatory coordinators, data managers, and study monitors
- Facilitate the timely development, review, and accuracy of clinical protocols, amendments, and study documentation
- Coordinate regulatory submissions and filings, including FDA IND, DSMB, and IRB requirements
- Oversee study data quality, review monitoring findings, and maintain audit-ready regulatory files
- Manage competing operational priorities across active studies while upholding patient care and protocol integrity
Skills
- Proactive, detail-oriented clinical research leader
- Proven project management expertise in IITs
- A grasp of clinical trial regulations
- Exceptional cross-functional communication skills
- Proven clinical research project management experience
- Comprehensive knowledge of clinical trial protocols, study documentation, and GCP regulations
- Direct experience with FDA IND, DSMB, and IRB submission processes
- Data review skills and ability to address and resolve monitoring findings
- Exceptional organizational, prioritization, and multidisciplinary communication skills
- Clinical research
- Clinical trial protocols
- Communication skills
- Preferably with Investigator-Initiated Trials (IITs)
Benefits
- Medical, prescription, dental, vision, AD&D, and life insurance offerings (based on eligibility)
- Short-term disability (based on eligibility)
- A 401K plan (based on eligibility)
Company Overview
Company H1B Sponsorship