Manager, Clinical Affairs - Transcatheter Heart Valve

Edwards Lifesciences Corp Irvine , CA 92606

Posted 11 months ago

As the Manager of Clinical Core Labs THV you will:

  • Manage and oversee the work of a small clinical operations team and may indirectly manage cross functional or matrix teams as appropriate.

  • Develop a robust talent development plan in alignment with functional growth strategies of the department.

  • Assess knowledge and/or quality gaps of clinical staff and determine appropriate training plans and/or needs.

  • Oversee the planning of Core Lab start-up activities (e.g., contracts, scope of work, case report form development, training materials) with accountability for successful completion within scope of project deliverables.

  • Maintain high level continuity of materials developed in collaboration with Core Labs and ensure alignment with internal and external stakeholder needs (e.g., THV Clinical Affairs, KOLs)

  • Provide strategic direction on field and remote monitoring of studies and data collection for all clinical trials; act as a Core Team lead; assess all data documentation (such as reports, records, transcripts, exam results)for consistency with case report form; and determine if clinical trial documentation is within parameters of study protocol, GCP (Good Clinical Practices) and regulatory requirements.

  • Lead in the identification of alignment opportunities in order to standardize processes across the organization and. Identify and mitigate risks due to multiple competing timelines and lead the implementation of course correction.

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Education/Qualifications:

  • Bachelor's degree in biological or Lifesciences, or other related scientific or technical field.

  • 10 years of previous related experience in Class II and III medical device technologies and/or clinical studies background required in clinical imaging and/or vendor management

  • Hands-on clinical research experience

  • Demonstrated track record in people management

  • Experience working in a regulated industry

  • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

  • Proven successful project management skills

  • Proven expertise in Microsoft Office Suite, including advanced Excel required

  • Excellent problem-solving and critical thinking skills

  • Expert understanding of clinical operations procedures while addressing issues with impact beyond own team based on knowledge of related disciplines

  • Extensive knowledge of human anatomy and physiology

  • Excellent problem-solving, organizational, analytical and critical thinking skills

  • Good leadership skills and ability to influence change

  • Strict attention to detail

  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

  • Ability to interact with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team

  • Ability to travel 20%.

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Manager, Clinical Affairs - Transcatheter Heart Valve

Edwards Lifesciences Corp