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Manager, Clinical Data Management

Company: JenaValve Technology, Inc.
Location: Irvine
Posted on: February 22, 2021

Job Description:

JenaValve is currently looking for a Manager, Clinical Data Management to contribute to the overall conduct and timely execution of JenaValve clinical trials by overseeing clinical database (design & validate, maintain and shutdown EDC) for clinical trials and overseeing data quality related appropriate clinical databases, and participating in the review and analysis of clinical data. This person will ensure the quality and integrity of data collected in clinical studies, the privacy of patient data and efficient recording and reporting of safety related issues. -- Responsibilities :

  • Oversee, manage, and participate in the development of clinical database design for JenaValve clinical studies, including User Acceptance Testing (UAT), query logic and language, edit checks, roles, and permissions and CRF completion guidelines and requirements as needed for specific databases.
  • Collaborate with the Director of Medical Affairs and other teams like Clinical Operations and Clinical Project Management team to develop Data Management Plans for study protocols, Data Surveillance Plans (as applicable) for clinical studies.
  • Develop EDC training materials and documentation.
  • Participate in data analysis with Clinical Project Management and statistical experts and consultants.
  • Manage timelines and milestones associated with database design, data review and database locks/freezes.
  • Oversee the overall quality of data and identifies key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns to key deliverables.
  • Work closely with the Clinical Project Management team, including study managers, clinical field monitors to ensure quality of clinical data through appropriate data collection and review.
  • Develop and manage data management quality documentation including Department Standard Operating Procedures (DSOPs) and Work Instructions (WIs) as needed.
  • Prepare and support vendor and agency audits as assigned.
  • Hire and manage clinical data team members as needed. Required Education and Experience :
    • 8+ years of experience in clinical data management is required (preferred in medical devices).
    • Technical skills in clinical databases and reporting tools (e.g. iMedidata, Medidata Rave, Oracle EDC) is preferred.
    • B.S. or B.A. in biological or medical/clinical sciences preferred with 5 years functioning as a lead data manager. Advanced degree is preferred.
    • Working knowledge of GCPs and regulatory requirements related to clinical research.
    • Working knowledge of data management practices.
    • Strong organization skills and time management in a dynamic environment; ability to work on multiple projects.
    • Good critical thinking and sound communication skills.
    • Self-motivated and detailed oriented. Skills and Abilities Required for This Job :
      • Knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device regulations and ICH Guidelines.
      • Experience working with all phases of study conduct: start-up, maintenance, and closeout.
      • Experience with PMA submissions and Clinical Trial Data Audits.
      • Experience writing SOPs and work instructions.
      • Must have ability to work collaboratively as part of a multi-functional medical device development team in a dynamic environment.
      • Excellent oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.
      • Ability to work in a fast-paced work environment within a cross-functional and highly interdependent team structure.

Keywords: JenaValve Technology, Inc., Irvine , Manager, Clinical Data Management, Healthcare , Irvine, California

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