Project Manager - Clinical Trials

Hackensack Meridian Health - Hackensack, NJ

Full-time

Hackensack, NJ

Hospitals

About the position

The Project Manager, Clinical Trials at Hackensack Meridian Health plays a crucial role in the development and implementation of comprehensive workflows and project/patient tracking procedures to ensure compliance across clinical trials. This position is responsible for overseeing the entire clinical research trials process, from initiation to final deliverables, ensuring that all activities are conducted in a timely and effective manner. The Project Manager collaborates closely with teams of investigators and research staff, emphasizing clarity in training and implementation while maintaining the highest standards of integrity. In collaboration with Clinical Investigators and the assigned Research Management Team, the Project Manager will develop clinical trial and patient flow manuals, Standard Operating Procedures (SOPs), and other necessary documentation required for the conduct of clinical trials. This role also coordinates all aspects of clinical trial feasibility, start-up, conduct, and close-out within the assigned Research Program or Division, ensuring that all trials progress according to Hackensack Meridian Health's quality standards and comply with state and federal regulations. The Project Manager is expected to apply all available knowledge, skills, tools, and techniques to effectively manage clinical trials, ensuring timely and accurate documentation, tracking, and reporting of all required data. This includes organizing and ensuring compliance with all requirements for internal and external research meetings, serving as a super user for the Clinical Trial Management System, and overseeing protocol feasibilities and site selection processes. Continuous process improvement is a key focus, with the Project Manager seeking opportunities to streamline operations and enhance trial performance. Additionally, the role involves acting as a liaison between investigators and funding agencies, participating in audits, and developing training materials for various stakeholders involved in clinical trials.

Responsibilities

• Initiate, plan, execute, monitor, control, and close all Clinical Trials within assigned Research Program or Division.
• Verify and ensure all assigned clinical trials are progressing according to HMH quality standards and state and federal regulations.
• Develop workflows, procedures, guidance, and/or Standard Operating Procedures for all aspects of study conduct for staff and patients.
• Ensure timely, accurate, and reliable documentation, tracking, and reporting of all required clinical trial study and patient data and metrics.
• Organize, track, report, and ensure compliance with all requirements for all routine and ad hoc internal and external research meetings.
• Serve as a Super User and team resource for the Clinical Trial Management System and Electronic Medical Records System.
• Oversee, track and coordinate protocol feasibilities, site selection, and startup processes including regulatory, finance, and contracts.
• Review study performance and accruals, identify potential study risks and road blocks, and escalate to management as appropriate.
• Provide regular reports to the PI regarding study progress and challenges.
• Organize and maintain active study slot allocation processes when applicable.
• Focus on continuous process improvement strategies within the assigned Research Program or Division.
• Assist study team in administrative aspects of clinical trial conduct and facilitate compliance efforts.
• Act as a liaison between the investigator and funding agency, and third party contractors for study-specific issues.
• Participate and ensure preparedness in both internal and external audits for data quality and regulatory compliance.
• Manage and ensure compliance with all Conflict of Interest algorithms and requirements for PI and site staff.
• Develop relationships with new physician referral networks and pharmaceutical/biotech companies.
• Develop and present training materials for investigators, coordinators, pharmacists, laboratory technicians, and monitors.

Requirements

• BA/BS diploma/degree in science or healthcare field
• Minimum of 8 years experience in Clinical Research roles with increasing responsibilities.
• Strong attention to detail and customer service focus.
• Ability to work independently or in a team and handle multiple deadline-driven tasks in a dynamic environment.
• Excellent organizational, presentation, documentation, and interpersonal skills.
• Excellent written and verbal communication skills.
• Proficient computer skills including Microsoft Office and/or Google Suite platforms.

Nice-to-haves

• Education on human subject research and GCP.