Clinical Project Manager


Job Description:

Clinical Project Manager play an important part in the clinical trial process.  The CPM position will perform a wide variety of activities to support the startup and completion of clinical research studies and may supervise other clinical operations personnel.

Responsibilities:

  • Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
  • Assesses the operational feasibility of studies and recommends execution and risk mitigation plans
  • Co-monitors as needed
  • Develops and tracks study timelines, budget, and quality metrics
  • Ensures appropriate clinical resources are available for the clinical project
  • Ensures GCP and regulatory compliance is maintained
  • Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
  • Maintains professional expertise through familiarity with therapeutic area and clinical research literature
  • Manages clinical projects from concept through clinical study report completion
  • Oversees clinical research study conduct
  • Manages, mentors, and develops direct reports
  • Organizes and leads the clinical project team.  Leads regularly scheduled cross-functional study team meetings with internal and external resources
  • Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts
  • Participates in meetings with investigative sites, key opinion leaders and consultants as needed
  • Plays a part  in the analysis, summary, and reporting of clinical data through the course of the study
  • Aides in the training and development of all clinical staff members
  • Performs other duties as assigned
  • Proactively identifies and resolves issues, and participates in process improvement initiatives as required
  • Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants
  • Reviews and approves invoices from study vendors, investigators, consultants, etc.
  • Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken
  • Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks

Job Requirements:

  • 5+ years clinical research experience in an industry setting and a minimum of 2 years project-lead or management experience
  • Medical Degree/Bachelor’s and/or master’s degree in a scientific discipline, RN, BSN degree or equivalent
  • Conscientious, influential person with an outstanding work ethic and strong personal discipline
  • Excellent organizational, leadership and problem-solving skills
  • Excellent written and verbal communication skills
  • Experience in leading cross-functional teams to meet goals and metrics
  • Success at managing global studies a plus
  • Know-how in managing Phase I, II, & III clinical studies
  • Experience in writing clinical study protocols, informed consent forms, and other clinical documents
  • Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
  • Solid understanding of NAFDAC, FDA and other regulatory requirements that may impact global clinical studies
  • Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
  • Willing and capable to manage multiple projects, negotiate budgets, timelines and responsibilities
  • Working knowledge of MS Project for development and update of clinical study timelines