Project Manager, Clinical Trials

Overview

Our team members are the heart of what makes us better.

At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community.

Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

The Project Manager of 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.

Responsibilities

A day in the life of a Project Manager of Clinical Trials at Hackensack Meridian Health includes:

• 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.

Qualifications

Education, Knowledge, Skills and Abilities Required:

• 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.

Education, Knowledge, Skills and Abilities Preferred:

• Education on human subject research and GCP.

Licenses and Certifications Preferred:

• Society of Clinical Research Associates Certification or Certified Clinical Research Administrator or Certified Clinical Research Professional.
• Project Management Professional Certification.

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!

Starting Minimum Rate

Starting at $95,555.20 Annually

Job Posting Disclosure

HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.

The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to:

Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness.
Experience: Years of relevant work experience.
Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training.
Skills: Demonstrated proficiency in relevant skills and competencies.
Geographic Location: Cost of living and market rates for the specific location.
Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization.
Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered.

Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts.

In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.