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Home-Based Senior Clinical Project Manager

New Jersey All, NJ

Posted: 12/11/2018 Job Type: Clinical Job Number: JN -122018-23234
  • Responsible for management of multiple projects (including global projects) throughout all lifecycle phases
  • Ensures that all project work is completed to the client expectations, ensuring quality deliverables on time and within budget and in accordance with SOPs, ICH GCP, applicable regulations, policies and practices
  • Serves as the principal liaison with clients to ensure effective and timely communication of project progress, issues, and plans for resolution of those issues
  • Provides leadership in the development of clinical trials and related documents
  • Works closely and effectively with cross-functional teams
  • Mentors and assists in the development of project team members, participates in the PM department initiatives, process improvement and training programs
  • Provides strategy and input in business development proposals and attends bid defenses
Duties and Responsibilities Duties include but are not limited to:
  • Plan, track and manage all activity throughout the project lifecycle, including deliverables from all functional areas and vendors in accordance with the project scope
  • Develop project plans, timelines and status reports and communicates with all applicable team members in and outside the organization
  • Promote effective teamwork among cross-functional teams and provide day to day direction for core team
  • Meet with team members on a regular basis regarding project tasks to ensure project milestones are meet
  • Collect information and provide input to line managers on team performance against contract, customer expectations and project baselines
  • Serve as primary project contact with clients to ensure communication is maintained and reporting schedules are adhered to
  • Manage project budget, communicate deviations from budget projections and propose solutions for budget deviations
  • Lead problem solving and resolution efforts. Provide proactive and creative recommendations on how to meet goals and handle identified risks and deviations
  • Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management
  • Ensure that work is conducted in compliance with professional standards and SOPs, and meet quality and timeline metrics
  • Build and maintain strong pharmaceutical industry sponsor and organizational team relationships for the success of clinical trial management
  • Define project workloads and assignments
  • Implement continuous process improvements for assigned projects
  • Mentor project managers and support staff
  • Participate in PM department initiatives and training programs
  • Participate in proposal development, bid-defense process and presentations
Competencies Knowledge:
  • Extensive knowledge of clinical research
  • Understands the drug development process
  • Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities
  • Ability to review protocols, programs, and assess the success of a project
  • Strong understanding and knowledge of budgeting, forecasting, and resource utilization
Minimum Qualifications:
  • Bachelor s Degree (4 year program); Preferred: Master s Degree
  • A minimum of 5-7 years of Clinical Project Management experience
  • Clinical Project Manager CRO experience is required
  • Oncology Early Development Clinical Research
  • Demonstrated leadership skills
  • Prior experience mentoring and/or training less senior team members
  • Experience managing study timelines, deliverables, and/or vendors
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