4326

Clinical Project Manager

Clinical Project Manager

Secaucus, NJ

Position title: Project Manager

Reports to: Associate Director, Project Management

Duties: Responsible for providing project oversight in order to maximize the effective use of project resources, to facilitate communication among team members, including study monitors, sponsor personnel, Frontage Clinical Research Center senior management, and investigative site personnel, to proactively problem solve issues, and to oversee the successful implementation and monitoring of clinical studies to facilitate their conduct in accordance with FDA GCP guidelines and applicable regulations. As necessary, create and maintain project Central Study Files

Qualifications: Requires a Bachelor’s or Master’s degree, preferably in a scientific discipline or equivalent experience.

Experience: A minimum of 5 years experience in clinical research is required.  A knowledge of FDA regulatory requirements is necessary.  Must have previous experience managing or assisting in managing projects and in monitoring clinical studies.  Good communication skills with the ability to interact with all levels of management and sponsor and study site personnel.

Specific Responsibilities:

  • If required, establishes and maintains a Central Study File at Frontage Clinical Research Center as a repository for study documents.
  • Assigns and coordinates Clinical Research Associate (CRA) study site monitoring activities.
  • Assesses CRA workloads relative to patient enrollment and study site performance.
  • Monitors overall patient enrollment tracking.
  • Monitors progress in evaluating, initiating, monitoring, and closing out study sites.
  • Monitors overall progress in retrieving clinical study data (case report forms) and data query resolution tracking.
  • Reviews correspondence between sponsor and Frontage Clinical Research Center project personnel and study site personnel, reviews monitoring visit reports, and assists in problem solving study site-related issues.
  • Selectively co-monitors at study sites and conducts in-house and on-site training of CRAs for prestudy site evaluations, study initiation visits, study monitoring visits, and study closeout visits and related activities.
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Acts as an advisor to subordinate(s) to meet schedules and/or resolve technical problems.
  • Develops and administers budgets, schedules, and performance requirements. Frequently interacts with subordinate supervisors, sponsors, and/or functional team members.
  • Regularly interacts with senior management on matters concerning resource allocation, project milestones, regulatory issues, and other relevant issues.
  • Manages and coordinates the activities of a project(s) with responsibility for results in terms of costs, methods, employees, and study completion.
  • Good communication skills with the ability to interface at all levels of management. In some instances this manager may be responsible for a functional area and may not have subordinates.

 

 

 

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