Project Manager, Clinical Trials

Hackensack Meridian Health•Hackensack, NJ

About The Position

The Project Manager, Clinical Trials develops and implements comprehensive workflows and project/patient tracking procedures and tools to ensure ongoing clinical trial compliance across the assigned Research Program or Division. This role oversees and drives the clinical research trials conduct process to final deliverables in a timely and effective manner. This role will manage, collaborate and communicate with teams of investigators and research staff to ensure continual process development and improvement, always emphasizing clarity in training and implementation with the highest standards of integrity. In collaboration with Clinical Investigators and the assigned Research Management Team, this role will be responsible for developing clinical trial and patient flow manuals of procedures, Standard Operating Procedures, and other necessary tools and documents required for conduct of clinical trials. In addition, this role will be responsible for coordinating all aspects of clinical trial feasibility, start-up, conduct and close-out of all Clinical Trials being conducted within their assigned Research Program or Division.

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 is essential.
Excellent organizational, presentation, documentation and interpersonal skills.
Excellent written and verbal communication skills.
Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.

Nice To Haves

Education on human subject research and GCP.
Society of Clinical Research Associates Certification or Certified Clinical Research Administrator or Certified Clinical Research Professional.
Project Management Professional Certification.

Responsibilities

Applies all available knowledge, skills, tools, and techniques to initiate, plan, execute, monitor and control, and close all Clinical Trials within assigned Research Program or Division.
Verifies and ensures all assigned clinical trials are progressing according to HMH quality standards and state and federal regulations at all times.
Develops workflows, procedures, guidance, and/or Standard Operating Procedures for all aspects of study conduct for staff and patients to ensure the full compliance and quality throughout the assigned Program/Division.
Ensures timely, accurate, and reliable documentation, tracking, and reporting of all required clinical trial study and patient data and metrics through routine collaboration with all research team members including but not limited to Investigators, Clinical Research Nurses, Clinical Research Coordinators, Regulatory and Study Start-Up Specialists, Clinical Data Coordinators, Study Contract and Finance Staff, Sponsors and Contract Research Organizations, and other team members throughout the HMH Network as required.
Organizes, tracks, reports, and ensures compliance with all requirements (i.e. agenda and minutes) for all routine and ad hoc internal and external research meetings including Research Program/Division research team meetings, contract and budget meetings, sponsor specific study meetings, and other meetings as required.
Serves as a Super User and team resource for the Clinical Trial Management System, Electronic Medical Records System, and all other systems required for the ongoing tracking and reporting of Clinical Trial Data and Performance Metrics.
Oversees, tracks and coordinates protocol feasibilities, site selection, and startup processes including regulatory, finance, and contracts to ensure efficient, competitive, and timely study start-ups and initiations.
Continually reviews study performance and accruals, identifies potential study risks and road blocks, and escalates to management as appropriate.
Provides regular reports to the PI regarding study progress and challenges and work with the PI to address any problems that arise.
Organizes and maintains active study slot allocation processes when applicable.
Focuses on continuous process improvement strategies both within the assigned Research Program or Division and throughout the entire HMH Research Enterprise, always seeking opportunities for streamlining and/or accelerating accruals to clinical trials, data cleaning, data quality, and trial completion.
Assists study team in administrative aspects of clinical trial conduct and facilitates all aspects of various governing agencies, study monitors, sponsors, and other compliance efforts. Guides on-site monitors by assisting in training, identifying issues to address at site level; assists with resolution of issues and tracking corrective action plans.
Acts as a liaison between the investigator and funding agency, and third party contractors for study-specific issues.
Participates and ensures preparedness in both internal and external audits for data quality, regulatory compliance, patient safety issues related to clinical trial participation. Communicate and coordinate compliance with all auditing responses and required process enhancements.
Manages and ensures compliance with all Conflict of Interest algorithms and requirements for PI and site staff.
Develops relationships and creates points of contacts with new physician referral networks and pharmaceutical/biotech companies.
Develops and presents training materials for investigators, coordinators, pharmacists, laboratory technicians, and monitors.
Maintains professional expertise through familiarity with therapeutic area, clinical research regulations, and project management expertise.
Other duties and/or projects as assigned.
Adheres to HMH Organizational competencies and standards of behavior.in the Medical Center's Organizational Competencies.