Cardinal Health Clinical Project Manager (Med Device) in Indianapolis, Indiana

What Clinical Project Management contributes to Cordis, a Cardinal Health Company

Clinical Project Management is responsible for strategic oversight and leadership direction within the Clinical Operations function.

Key Activities and Accountabilities:

The Clinical Project Manager is responsible for driving the clinical strategy and managing the execution of Cordis global clinical studies in support of business and regulatory objectives.

  • Leads project teams through planning, execution and management of all operational aspects of clinical studies
  • Leads, directs and executes clinical studies worldwide in accordance with approved clinical strategy, project plans, budget and resources in compliance with applicable regulatory requirements and standard operating procedures
  • Establishes and maintains successful collaboration and partnerships with third party vendors (e.g. CROs, core labs, etc.), study investigators and site research personnel to facilitate successful execution of clinical studies
  • Supports development and maintenance of internal and external clinical study materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions
  • Ensures the clinical project team maintains a continuous state of audit readiness
  • Leads proactive identification, assessment, and management of clinical study risks
  • Demonstrates advanced knowledge and understanding of project management methodologies and relevant clinical operations
  • Manages implementation projects independently in a more complex environment
  • Facilitates strategic decisions to optimize implementation projects specific to the management of scope, financials and schedule
  • Anticipates project risks and develops mitigation strategies/plans for more complex risk factors
  • Serves as a resource and/or mentor to less experienced members of the Clinical Operations team
  • Presents and communicates study progress to senior level clinical and business leadership
  • Uses tact and diplomacy to resolve conflicts across project team members and customers
  • Leads and directs the discussions with the project team and customers to define scope and project requirements
  • Influences internal and external customer expectations so ensure alignment
  • Communicates clearly and effectively across all levels of the organization

Qualifications

  • Undergraduate degree required
  • Advanced degree preferred
  • 4 - 6 years of industry experience in managing medical device clinical studies
  • Clinical studies experience in the cardiovascular or peripheral vascular area preferred

What is expected of you and others at this level

  • Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
  • May contribute to the development of policies and procedures
  • Works on complex projects of large scope
  • Develops solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
  • Completes work independently receives general guidance on new projects
  • Work reviewed for purpose of meeting objectives
  • May act as a mentor to less experienced colleagues

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Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.