TMF Supervisor I, Clinical Operations THV, Irvine, Ca

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

Job Description:

Supervisor I, Clinical Records Management, THV, Irvine, Ca The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide. The Supervisor I Clinical Records Management will supervise the team of employees that manage clinical records within the BU. Key Responsibilities:

• Supervise employees and oversee the daily work activities including assessing daily progress within all aspects of the eTMF (electronic trial master file) including accuracy, completeness and compliance of documentation in multiple clinical research trials
• Lead sections of improvement projects in collaboration with cross-functional teams
• Provide feedback and/or conduct performance reviews on employees, including resolving performance issues.
• Provide training and improve training plans for assigned and/or cross-functional team(s)
• Gather data via data reporting and provide basic assessment to management
• Represent Clinical Records Management and provide subject matter expertise for internal and external audits including follow up corrective actions and effectiveness monitoring under some guidance from management
• Lead team with production, distribution and tracking of study materials (e.g. study binders and patient recruitment materials) to clinical sites
• Lead in the development, maintenance and management of internal study training matrices and tracking of respective training records. Education and Experience:
  • Bachelor's Degree or Equivalent in in related field with substantial technical clinical operations knowledge Required or Associate's Degree or equivalent
  • 4 years of previous related experience Required Additional Skills:
    • Full responsibility for all personnel including hire/fire authority and handling all aspects of employee relations
    • Strong computer skills in Microsoft Office Suite; Experience with Clinical Systems (e.g., CTMS (Clinical Trial Management System), electronic Trial Master file (e.g., Veeva eTMF) preferred
    • Experience with Class II & III medical devices preferred
    • Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives
    • Full knowledge and understanding of Edwards policies and procedures related to assigned phase within assigned area of responsibility
    • Full knowledge and understanding of international regulations of Good Clinical Practice (GCP)
    • Full knowledge and understanding of diverse and applicable regulations and standards relevant to medical devices (e.g., 21 CFR Part 11/50/54/56/801/803/806/807/820/812/814/821/822, ISO 14155; ICH E6)
    • Full knowledge of clinical trials and regulatory requirements
    • Full knowledge of medical terminology
    • Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
    • Ability to lead teams, provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
    • May represent the organization to outside contacts, e.g., vendors, suppliers, contractors, staffing agencies
      -- 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 patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria , 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 , TMF Supervisor I, Clinical Operations THV, Irvine, Ca, Healthcare , Irvine, California