Hackensack Meridian Health-posted 3 months ago
Full-time • Manager
Hackensack, NJ
5,001-10,000 employees

The Manager, Project Management Oncology Research manages the Oncology Clinical Research Project Management Team including the Project Managers and the Clinical Research Coordinators. This role is responsible for ensuring that all aspects of clinical research operations are managed, tracked, and reported according to investigator, sponsor, departmental, NCI, and HMH requirements and maintaining full regulatory compliance at all times. In addition, this role is responsible for successful planning, implementation, and execution of ongoing comprehensive process improvement for all aspects of Oncology Clinical Research Operations. This role supports the department director in the ongoing development of functional training, definition of standards, and execution of department goals, including process improvement and assures clear communication, process documentation, and compliance with Good Clinical Practices and procedures.

  • Manages the Project Management team to ensure consistency, regulatory compliance, and continuous process improvement across the Oncology Clinical Research enterprise.
  • Develops and maintains Clinical Trial Management System process and procedures to continually enhance and automate Oncology Clinical Research metrics tracking and reporting across all disease groups (oncology divisions).
  • Manages the Clinical Research Coordinator team to ensure consistent and regulatory compliant operational and administrative support across assigned study teams.
  • Develops and maintains processes and procedures to ensure strong and effective matrix team communications and to enable efficient and effective clinical trial execution across all participating sponsors, vendors, departments, physicians, and team members and HMH leadership.
  • Works alongside Physicians, Leadership, and research executives to operationalize new and existing research programs and initiatives.
  • Contributes to the scientific and operational review of projects and assessment of study and accrual feasibility.
  • Works with Project Management Team to ensure the active ongoing management of all Clinical trial portfolios including providing direction and leadership to implement new initiatives to accelerate clinical trial startup by reducing budget, Medicare Coverage Analysis and Pharmaceutical company cycle times on all contract and budget negotiations.
  • Accountable for meeting research participant recruitment performance metrics and divisional operations targets through the direction and management of Project Management and Clinical Research Coordinators.
  • Fosters collaborative working relationships with cross-functional research teams (i.e., nursing, data management, regulatory, finance, and others) in order to align processes, maximize efficiency, and drive timely and quality project delivery.
  • Ensures direct reports submit high quality, accurate and timely data into information systems (e.g., CTMS, clinical trial databases, EPIC EMR and other tracking systems) that generate operations, financial, NCI, regulatory and other leadership reports.
  • Defines and measures accrual and other performance metrics and provides executive leadership with regular status updates on productivity, progress of the trials, and identifies opportunities of risk and/or improvement.
  • Accountable for the recruitment, supervision, performance management and evaluation (including progressive disciplinary measures) of Project Managers and Clinical Research Coordinators.
  • Promotes and maintains organizational efficiency and effectiveness.
  • Communicates and openly supports new policies and procedures and strategic priorities as outlined by the Research Director and other research initiatives.
  • Maintains a positive work climate; applies policies fairly and consistently and fosters an environment where employees contribute to the organization.
  • Maintains overall awareness in the field of clinical research, as well as assigned areas.
  • Other duties and/or projects as assigned.
  • Adheres to HMH Organizational competencies and standards of behavior.
  • Bachelor's Degree required, advanced degree preferred (MS, PhD).
  • Minimum of 10 years of experience in the healthcare field.
  • Minimum of 5 years of direct experience in Clinical Research Operations.
  • Minimum of 3 years of progressive direct management experience.
  • Strong attention to detail and customer service focus.
  • Excellent communication, organizational, interpersonal and presentation skills.
  • Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
  • Proficiency in Microsoft Office Suite and Google Workspace.
  • Extensive knowledge of drug development process and clinical trial execution.
  • Advanced Degree in research field or related field.
  • Health insurance
  • Dental insurance
  • Vision insurance
  • Paid leave
  • Tuition reimbursement
  • Retirement benefits
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