Sr. Clinical Data Manager

Sr. Clinical Data Manager

LivaNova

Milan, Italy

Position Summary:

  • Responsible, with limited direction, for planning and executing clinical data management activities in clinical studies or projects ensuring that deliverables are met in timelines and quality.
  • Ensures that data management deliverables of a clinical study or across clinical studies meet:
    • Good Clinical Data Management Practices
    • regulatory requirements
    • operational efficiency
    • full alignment with the overall clinical strategy
  • Ensures data management deliverables are appropriate while keeping with the needs of internal and external stakeholders.
  • May administratively and functionally manage a data management team, being accountable of their deliverables and responsible to provide appropriate leadership.

Essential Job Functions:

  • With limited direction, responsible for planning and executing clinical data management activities in clinical studies and data management teams.
    • provide data management input during the protocol development on assigned studies
    • facilitate CRF/eCRF design ensuring all data required per specifications in the protocol are captured appropriately on the CRFs
    • lead the development of the eCRF design specifications, data transfer agreements, UAT execution, and query check specifications
    • develop, document, and maintain data management study related documentation including and provide study-specific data management training for team members as necessary
    • develop edit check content, manage data query generation and resolution
    • oversee data review activities within the clinical database
    • lead AE/SAE and Device Discrepancy reconciliation of clinical data
    • oversee device and external data receipt and management activities
    • coordinate database lock procedures, including all QC efforts, in-line with LivaNova database lock requirements
  • Ensures that all activities under responsibility are properly documented (traceability of changes, data specifications) according to the internal guidance documents
  • Exhibits routine and complex problem solving skills.
  • Keeps abreast and look for opportunities for applying innovative data management methods and enhancements.
  • Understands and follows all Global Biometrics Quality Documents.
  • Reviews/contributes to project management plan of clinical activities and ensure that deadlines are met.
  • Implements and maintains data standards and dataset structures.
  • Develops, applies and maintains standard database specifications, edit checks, and data review tools.
  • Leads and participates in clinical and infrastructure projects, act as LivaNova internal subject matter expert related to data management processes and standards.
  • Encourages and maintains quality in the data management activities.
  • Collaborates effectively with Global Biometrics internal and external partners in all activities where handling and reviewing of clinical data is needed.
  • Communicates technical clinical data management concepts in a clear, concise, focused, and articulate manner.
  • Works according to ICH-GCP, other international guidelines (e.g., ISO), working group recommendations (e.g., CDISC or Good Clinical Data Management Practices) as well as internal quality system.
  • May administratively manage a small team.
  • Performs other tasks as per line management discretion.

Knowledge, Skills, and Abilities Required:

Technical skills:

  • Technically proficient to understand and to implement clinical data management methods in the activities under responsibilities
    • technical experience in leading the design, build, and validation activities of CDMS and EDC platforms
    • clinical understanding of medical terminology, medical terms coding, and adverse event reporting

Competencies:

  • Decision making 3 = Advanced
  • Communication 3 = Advanced
  • Leverage 3 = Advanced
  • Prioritization 3 = Advanced
  • Operational excellence 3 = Advanced
  • Strategic thinking 3 = Advanced
  • Creativity 3 = Advanced
  • Result focus 3 = Advanced
  • Problem solving 4 = Able to teach
  • Customer satisfaction 3 = Advanced

Education:

  • Desirable to have an university degree (at least BSc) preferably in Computer Science, Life Science, or other relevant field, with excellent track record in clinical data management.

Experience:

  • More than 8 years of experience in a clinical data management team during study startup, conduct, and database lock phases in pharmaceutical, medical device, or CRO
  • Successfully managed clinical data management activities with full responsibility and independence
  • Experience with representing the data management team, such as reporting study status and participating in study team discussions, with study stakeholders
  • Experience with providing study metrics and/or data entry metrics

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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