CRO - Project Director

Evolution Research Group US,
Remote

About The Position

Project Director provides leadership and support to members of assigned project teams. Responsibilities include oversight of the projects including budgeting, timeline adherence, internal and external communications, project deliverables and management of all Project Managers completing these tasks for assigned projects. In conjunction with Chief Operating Officer and the VP of Quality Operations, acts as a point of escalation and liaison between sponsors, team members, and the cross-functional organization for assigned projects.

Requirements

  • Bachelor’s degree or equivalent education/degree in life science/healthcare is required.
  • Minimum of 4 years of working within clinical project management either at an investigational site, pharmaceutical company, or CRO.
  • Minimum of 8 years of experience within clinical research.
  • Extensive knowledge of the FDA submission process.
  • Ability to facilitate a teamwork philosophy with a positive attitude.
  • Extensive supervisory, teaching and facilitation skills with the ability to assess training needs and objectives.
  • Extensive experience overseeing and coordinating the work of others.
  • Ability to work effectively and efficiently handling multiple tasks simultaneously.
  • Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
  • Ability to manage multiple deadlines.
  • Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.
  • Strong computer skills, including Microsoft Office.

Nice To Haves

  • Prior CRO experience
  • Experience supervising projects

Responsibilities

  • Reviewing project KPI reports and compiling reports for senior management.
  • Working with the Project Manager to ensure appropriate change management for assigned projects.
  • Providing direction and serving as a point of escalation for project issues and risks.
  • Overseeing development, governance, and implementation of processes, methodologies, tools for assigned projects/programs.
  • Working with Directors to ensure appropriate project resources for assigned projects.
  • Participating in the hiring of project management staff as needed.
  • Interfacing with internal departments to develop organization work structure for programs.
  • Facilitate approval for project management deliverables for assigned project such as: Project Transfer of Responsibilities/Obligations document, Project-specific plans/manuals, scope, timelines, and budget projections, Status reports.
  • Manage project management processes for assigned projects such as: Risk management, Issue management, Change control, Quality management, Project evaluation, Client relationships.
  • Serve as a Project Manager and assume primary accountability for overall project scope, deliverables, budget, and timelines for assigned clinical research projects, ensuring compliance with applicable regulations, guidelines, and corporate policies for study activities.
  • Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
  • Attends off-site meetings and conferences, as needed.
  • Ensures that project milestones are met and documented.
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