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Analyst, Clinical Contracts Trials and Sites - THV

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: November 19, 2021

Job Description:

Analyst, Clinical Contracts Trials and Sites - THV This is a unique opportunity to join an innovative growing group, Transcatheter Heart Valve Unit (THV), focused on developing solutions for patients suffering from structural heart disease. The Analyst Clinical Contracts will negotiate and develop contracts associated with clinical trials, ensure contracts comply with regulations and manage the lifecycle of contracts.

Key Responsibilities:

  • Specific to clinical trial sites, prepare initial contract(s) and draft(s); redline and negotiate contracts, utilizing Legal Department templates. Demonstrate clinical knowledge and adhere to regulatory requirements. Assist in proposing new language for templates.--
  • Negotiate site-specific clinical trial budgets for per-patient procedures and trial-related costs based on basic financial knowledge and in adherence with regulatory requirements.--
  • Identify risks and analyze potential impact to company; communicate risk to key stakeholders.
  • Communicate and collaborate with key internal stakeholders, including THV Project Managers, Legal, Compliance and Finance to obtain or clarify data required for budgets and contracts; share contracting strategies and discuss potential risks to trial timelines and deliverables.
  • Collaborate with external stakeholders (hospital and/or university research office, finance office, and external or internal counsel) to negotiate budgets and contracts and to collect required documentation for executed contracts.
  • Submit proposed final draft and supporting documentation through Legal Department's electronic contracts management system for contract approval and secure appropriate signatures within specified signing authority. Utilize company systems to store executed contracts and manage on-going assignments. Education and Experience:
    • Bachelor's Degree in in related field required
    • Minimum 3 years of previous related experience in contract negotiation/administration and financial tracking/analysis against contracts.
    • Experience in healthcare related contracts is preferred Additional Skills:
      • Proven expertise in Microsoft Office Suite, including PowerPoint, Excel, and Word and ability to operate general office machinery
      • Good written and verbal communication skills and interpersonal relationship skills
      • Demonstrated problem-solving and critical thinking skills
      • Moderate knowledge and understanding of Edwards policies, procedures and guidelines relevant to contract negotiation and administration
      • Moderate knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
      • Moderate understanding of regulatory requirements (e.g., CFR, GCP) and documents
      • Advanced proficiency in Microsoft Office Suite, including Excel, and Word
      • Ability to manage confidential information with discretion
      • Strict attention to detail
      • Ability to interact professionally with all organizational levels
      • Ability to manage competing priorities in a fast paced environment
      • Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific project
      • --Ability to build productive internal/external working relationships E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.-- Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.-- For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Keywords: Edwards Lifesciences Gruppe, Irvine , Analyst, Clinical Contracts Trials and Sites - THV, Professions , Irvine, California

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