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Job Title: Project Manager, Clinical Trials

Job Description

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.

Pay and Benefits

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

Hackensack Meridian Clinical Project Manager

Workplace Type

This is a hybrid position in Hackensack,NJ.

Application Deadline

This position is anticipated to close on Aug 12, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.