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Senior Clinical Project Management

Expired Job

Cardinal Health Milpitas , CA 95035

Posted 3 months ago

What Clinical Ops Project Mgmt contributes to Cardinal Health

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

  • The Senior 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

  • Coordinates development of clinical investigational plans, clinical study reports and annual progress reports

  • 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

  • Independently manages clinical studies of medium and high complexity

  • Coordinates investigator, site and vendor selection

  • Facilitates strategic decisions to optimize implementation projects specific to the management of scope, financials and schedule

  • Manages budgets and timelines for multiple clinical studies/programs

  • Anticipates project risks and develops mitigation strategies/plans for more complex risk factors

  • Serves as a resource and/or mentor to all levels 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 external stakeholders

  • 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

  • Exercises independent judgment in developing methods and techniques for obtaining results

Qualifications

  • Undergraduate degree required, preferably in science

  • Advanced degree preferred

  • 6-8 years of experience managing medical device studies required

  • Experience managing clinical studies in cardiovascular and peripheral vascular areas preferred

What is expected of you and others at this level

  • Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects

  • Participates in the development of policies and procedures to achieve specific goals

  • Recommends new practices, processes, metrics, or models

  • Works on or may lead complex projects of large scope

  • Projects may have significant and long-term impact

  • Provides solutions which may set precedent

  • Independently determines method for completion of new projects

  • Receives guidance on overall project objectives

  • Acts as a mentor to less experienced colleagues

#LI-MD1

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.


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Senior Clinical Project Management

Expired Job

Cardinal Health