Clinical Project Manager

Position Overview

• Location Type: Not Specified
• Job Type: Full time
• Salary: Not Specified

This role is responsible for managing clinical development projects, ensuring successful and timely completion while adhering to project guidelines and client requirements.

Responsibilities

• Project Planning & Execution:
  • Identify project guidelines and communication needs by reviewing study requirements and response assessment criteria.
  • Collaborate with stakeholders to develop study start-up activities and associated documents.
  • Define project plans, including timelines, milestones, and limitations for project staff.
  • Establish project reporting schedules and provide updates to BD Director, Global Services Managing Directors, and Sponsor representatives.
  • Communicate project information to project teams, sites, and company/sponsor representatives.
• Project Analysis & Management:
  • Identify critical project success factors for tracking, analysis, and reporting.
  • Determine resource needs for project completion and communicate them to departmental managers.
  • Collaborate with department leaders for appropriate training of project staff.
  • Perform financial tasks including monthly billing, forecasting, project scope reviews, amendments, and pass-through cost management.
  • Maintain a thorough understanding of project contracts and revenue reporting requirements.
  • Understand SOPs and work closely with QA for clarification and documentation of deviations.
  • Train and maintain project team knowledge and application of SOPs.
  • Communicate protocol clarifications/revisions to the project team.
  • Coordinate site management of data collection with internal and external teams.
• Project Team Leadership:
  • Lead by example with professional and collaborative conduct.
  • Develop and deliver team project training.
  • Establish team performance expectations and guidelines.
  • Provide input to departmental managers on team members' performance.
  • Analyze team performance for consistency and quality.
  • Collaborate with departmental managers for team coaching and mentoring.
• Business Development Support:
  • Collaborate with the BD Director in developing and presenting company capabilities.
  • Attend professional meetings as a Company representative.
  • Deliver Investigator Meeting presentations.
• Project Close Out:
  • Assist with the coordination of submission activities.
  • Initiate and oversee all project close-out activities.
• Supervisory Functions (if applicable):
  • Communicate job expectations, monitor, and appraise job results.
  • Coach, counsel, and discipline staff.
  • Enforce systems, policies, and procedures.
  • Approve direct reports' time sheets and time off requests.
  • Perform timely performance evaluations of direct reports.
  • Coordinate and conduct new hire interviews and hiring decisions.
  • Train new hires on departmental processes and responsibilities.
• Quality Service & Departmental Standards:
  • Adhere to organizational Standard Operating Procedures (SOPs).
  • Establish and enforce departmental standards.
  • Review and update company SOPs.
• Secondary Responsibilities:
  • Explore new opportunities to add value to the organization and departmental processes.
  • Assist colleagues in achieving results.
  • Perform other assigned duties.
• Technical Knowledge:
  • Attend and participate in applicable company-sponsored training.

Requirements

• Education:
  • Bachelor’s degree required or commensurate experience level.
  • Majors in life sciences, pharmacy, nursing, or other healthcare fields highly desirable.
• Experience:
  • Previous management or project experience in clinical development of investigational medications required.
  • 1-3 years of clinical trials experience.