Project Manager, Clinical Trials

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.

• Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors,

• Regulatory Specialists Contract Research Organizations, and employees of Hackensack University Medical Center.

• 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; assist 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.

Additional Skills & Qualifications:

• Bachelor's degree in a scientific or medical discipline with at least 3 years of experience in clinical research.

• Experience in clinical protocol and trial document development.

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

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 actalentaccommodation@actalentservices.com for other accommodation options.