Clinical Operations Project Manager

2 weeks ago

Marlborough, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Collaborates with business leaders and/or Program owners to support the identification and prioritization of programs/projects that advance strategic initiatives and translate business strategy into project goals/measurable objectives
  • Develops, manages and implements charters and project plans outlining work plans, timelines, roles, and resources for multiple tracks of work.
  • Directs project execution by assigning tasks, managing project resources, working with subject matter resources, tracking project schedules, mitigating risks/issues, and developing and executing contingency plans
  • Track and manage risks, actions, issues, decisions, and metrics for the overall project, escalate/drive risks and issues to resolution and ensure project team members are completing deliverables in alignment with the timelines
  • Works with functional team members to ensure that all supporting infrastructure including program guidelines, processes, training programs are developed and communicated.
  • Develops, manages and executes a project communication and training plan and supports the increased connectivity of the Global Clinical Operations teams by providing updates to senior management and all stakeholders of progress through frequent communications of findings at regular intervals via reports, meetings and other channels.
  • Consistently strives to identify opportunities to introduce efficiencies to our clinical processes and assists in the development of portfolio management practices, project related document library, best practice sharing platform and other initiatives that continue to evolve the Global Clinical Operations teams.
  • Supports the increased connectivity of Global Clinical Operations to the Divisions and key partners/functions
  • Acts as a mentor to provide project management guidance and coaching to project team members and/or to others outside of the project
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Requirements :
  • Bachelor's Degree, or an equivalent combination of experience and education
  • 5+ years experience leading and working on projects with multiple workstreams
  • A minimum of 3 years of experience in clinical research
  • Strong leadership, collaboration, project management, communication, and change management skills
  • Proven organizational skills and clear and concise communications
  • Demonstrated ability to develop collaborative partnerships with a variety of internal & external stakeholders throughout all levels of the organization
  • Ability to diagnose problems which could be related to strategy, process, technology, or people and collaborate with workstreams and leadership to put in place appropriate actions/measures
  • Demonstrated experience managing multiple projects concurrently
Preferred Qualifications:
  • Experience following quality management standards within a life science and/or medical device regulatory framework
  • Keen interest / experience in identifying improvement opportunities, challenging status quo, driving functional excellence
  • Familiar working with Clinical systems: Electronic Data Capture (EDC), Clinical Trial Management System (CTMS)

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