Project Manager, Clinical Trials

Project Manager In Clinical Trials

The Project Manager in Clinical Trials will oversee multiple investigator-initiated clinical trials, ensuring the successful management and execution from concept to final deliverables. This role involves collaboration with research team members, acting as a liaison between investigators, funding agencies, and third-party contractors, and overseeing compliance efforts and statistical analysis.

Responsibilities

• Manage multiple investigator-initiated clinical trials.
• Oversee reports and assist with statistical analysis.
• Assist study teams in preparing audits for governing agencies and study monitors.
• Drive projects to completion, resulting in publications and clinical study reports.
• Act as a liaison between investigators, funding agencies, and third-party contractors.
• Collaborate daily with Principal Investigators, Research Nurse Coordinators, Sponsors, Regulatory Specialists, and Contract Research Organizations.
• Coordinate preparation and development of protocols, informed consent forms, monitoring plans, and validation plans.
• Oversee submission of IND Applications to FDA as needed.
• Design case report forms and liaise with data analysts for database development.
• Coordinate study manuals of procedures for site coordinators, pharmacists, and laboratory technicians.
• Develop and present training materials for investigators and coordinators.
• Verify trials progress according to quality standards and federal regulations.
• Guide on-site monitors, providing training and resolution of issues.
• Arrange, prepare, and document meetings between clinical researchers, sponsors, and coordinating center members.
• Build research infrastructure to support multi-center clinical trials.
• Perform project management for ad hoc JTCC projects as needed.
• Adhere to standards identified in the Medical Center's Organizational Competencies.

Essential Skills

• 8+ years of clinical research experience.
• Bachelor's degree in a scientific or medical discipline.
• Experience in clinical protocol and trial document development.
• Solid knowledge of Good Clinical Practice guidelines.
• Understanding of Protection of Human Subjects regulations.

Additional Skills & Qualifications

• Experience with informed consent forms, investigational device exemption, serious adverse event reporting.
• Experience with IND safety reports and Institutional Review Board procedures.

The pay range for this position is $100000.00 - $126000.00/yr.

Hackensack Meridian Clinical Project Manager

This is a hybrid position in Hackensack, NJ.

This position is anticipated to close on Sep 17, 2025.