Clinical Research Manager

7 days ago

Hackensack, United States Actalent Full time

Job Title: Clinical Research Manager

Job Description

  • Manages multiple investigator-initiated clinical trials.

  • Oversees reports and assists with statistical analysis. Assists study team in the preparation of all audits performed by various governing agencies, study monitors, and other compliance efforts.

  • Oversees and drives projects from concept to final deliverables in form of publications, clinical study reports, final reports to funding agency, etc.

  • Acts as a liaison between the investigator and funding agency, and third-party contractors for study-specific issues.

  • Coordinates preparation of and assists with the development of protocols, informed consent forms, monitoring, and validation plans.

  • Oversees submission of IND Application to FDA as needed.

  • Designs case report forms and liaises with data analyst for database development.

  • Coordinates study manuals of procedures for site coordinators, pharmacists, and laboratory technicians.

  • Develops and presents training materials for investigators, coordinators, pharmacists, laboratory technicians, and monitors.

  • Verifies trials are progressing according to quality standards and federal regulations.

  • Guides on-site monitors by providing training, identifying issues to address on-site, assisting with resolution of issues, and tracking corrective action plans (if CRO).

  • Arranges, prepares for, and documents meetings between clinical researchers, sponsors, and coordinating center members.

  • Builds research infrastructure to support multi-center clinical trials. Performs project management for ad hoc JTCC projects as needed.

  • Adheres to the standards identified in the Medical Center's Organizational Competencies.

Hard Skills

  • 8+ years of clinical research experience

  • 1+ years management experience

  • Oncology experience preferred but not needed

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are Embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

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 process due to a disability, please email (see below) (% (see below) ) for other accommodation options.

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