Sr. Clinical Data Manager


  • Company:
    Sorin
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    3 days ago
  • Category:
    IT & Software

Job Title
:
SENIOR CLINICAL DATA MANAGER
Department
:
Global Biometrics
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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.
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Ensures that data management deliverables of a clinical study or across clinical studies meet:
o
Good Clinical Data Management Practices
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regulatory requirements
o
operational efficiency
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full alignment with the overall clinical strategy
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Ensures data management deliverables are appropriate while keeping with the needs of internal and external stakeholders.
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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.
o
provide data management input during the protocol development on assigned studies
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facilitate CRF/eCRF design ensuring all data required per specifications in the protocol are captured appropriately on the CRFs
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lead the development of the eCRF design specifications, data transfer agreements, UAT execution, and query check specifications
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develop, document, and maintain data management study related documentation including and provide studyspecific data management training for team members as necessary
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develop edit check content, manage data query generation and resolution
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oversee data review activities within the clinical database
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lead AE/SAE and Device Discrepancy reconciliation of clinical data
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oversee device and external data receipt and management activities
o
coordinate database lock procedures, including all QC efforts, inline with LivaNova database lock requirements
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Ensures that all activities under responsibility are properly documented (traceability of changes, data specifications) according to the internal guidance documents
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Exhibits routine and complex problem solving skills.
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Keeps abreast and look for opportunities for applying innovative data management methods and enhancements.
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Understands and follows all Global Biometrics Quality Documents.
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Reviews/contributes to project management plan of clinical activities and ensure that deadlines are met.
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Implements and maintains data standards and dataset structures.
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Develops, applies and maintains standard database specifications, edit checks, and data review tools.
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Leads and participates in clinical and infrastructure projects, act as LivaNova internal subject matter expert related to data management processes and standards.
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Encourages and maintains quality in the data management activities.
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Collaborates effectively with Global Biometrics internal and external partners in all activities where handling and reviewing of clinical data is needed.
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Communicates technical clinical data management concepts in a clear, concise, focused, and articulate manner.
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Works according to ICHGCP, other international guidelines (e.g., ISO), working group recommendations (e.g., CDISC or Good Clinical Data Management Practices) as well as internal quality system.
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May administratively manage a small team.
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Performs other tasks as per line management discretion.
Knowledge, Skills, and Abilities Required
:
Technical skills:
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Technically proficient to understand and to implement clinical data management methods in the activities under responsibilities
o
technical experience in leading the design, build, and validation activities of CDMS and EDC platforms
o
clinical understanding of medical terminology, medical terms coding, and adverse event reporting
Competencies:
·
Decision making
3 = Advanced
·
Communication
3 = Advanced
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Leverage
3 = Advanced
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Prioritization
3 = Advanced
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Operational excellence
3 = Advanced
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Strategic thinking
3 = Advanced
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Creativity
3 = Advanced
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Result focus
3 = Advanced
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Problem solving
4 = Able to teach
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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
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Successfully managed clinical data management activities with full responsibility and independence
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Experience with representing the data management team, such as reporting study status and participating in study team discussions, with study stakeholders
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Experience with providing study metrics and/or data entry metrics