• Project Manager, Clinical Trials

    Actalent (Hackensack, NJ)


    Job Title: Project Manager, Clinical TrialsJob Description

     

    The Project Manager for Clinical Trials will manage multiple investigator-initiated clinical trials, overseeing reports and assisting with statistical analysis. You will be responsible for assisting the study team in preparing for audits by various governing agencies, study monitors, and other compliance efforts. The role includes overseeing and driving projects from concept to completion, resulting in publications, clinical study reports, and final reports to funding agencies. Additionally, you will act as a liaison between investigators, funding agencies, and third-party contractors, ensuring smooth communication and resolution of study-specific issues.

    Responsibilities

    + Collaborate with research team members including Principal Investigators, Research Nurse Coordinators, Sponsors, Regulatory Specialists, Contract Research Organizations, and medical center employees.

    + Coordinate and assist in developing protocols, informed consent forms, monitoring, and validation plans.

    + Oversee the submission of IND Applications to the FDA as needed.

    + Design case report forms and work 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, coordinators, pharmacists, laboratory technicians, and monitors.

    + Ensure trials progress according to quality standards and federal regulations.

    + Guide on-site monitors by providing training, identifying issues, assisting with issue resolution, and tracking corrective action plans.

    + Arrange, prepare for, 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 projects as needed.

    + Adhere to the standards identified in the Medical Center's Organizational Competencies.

    Essential Skills

    + 8+ years of clinical research experience.

    + Experience in clinical protocol and trial document development.

    + Solid knowledge of Good Clinical Practice guidelines and Protection of Human Subjects regulations.

    Additional Skills & Qualifications

    + Bachelor's degree in a scientific or medical discipline.

    + Experience with informed consent forms, investigational device exemption, serious adverse event reporting, IND safety reports, and IRB processes.

    Work Environment

    The work environment is within a leading healthcare system that is part of the National Cancer Institute-designated comprehensive cancer center. You will be part of a team that evaluates novel cancer treatments and technologies, providing patients with increased access to clinical trials. The healthcare system offers a complete spectrum of services, allowing you to apply your skills in various settings while advancing your career. Recognized as a top cancer center, the organization provides innovative cancer care, with a focus on patient-centered treatment plans.

     

    Job Type & Location

     

    This is a Permanent position based out of Hackensack, New Jersey.

    Pay and Benefits

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

     

    HMH Perm benefits offered

     

    Workplace Type

     

    This is a hybrid position in Hackensack,NJ.

     

    Application Deadline

     

    This position is anticipated to close on Oct 30, 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.