Senior Clinical Data Manager

Senior Clinical Data Manager

Cytel

United Kingdom

The Senior Clinical Data Manager is responsible for the performance of data management tasks from study start-up through database lock for assigned clinical research projects, including paper-based and electronic data capture (EDC) studies, and is responsible for overall data consistency and documentation on clinical research projects.

Specific responsibilities include start-up activities such as:

  • Contributing to protocol design.
  • Development of project forms to meet project needs.
  • Creation, review and finalization of case report forms (CRFs).
  • Database design and preparation of data validation specifications; and ensuring consistency in database and CRF design.

Additional responsibilities include:

  • Preentry preparation of forms for data entry.
  • Data review and discrepancy management.
  • Coding of data such as adverse events or medications using the appropriate dictionary(ies).
  • Training clinical research associates to help improve the quality of data being collected.
  • Producing summaries and listings of clinical study data, as required.
  • Handling external data; database quality control.
  • And final database lock..

The Senior Clinical Data Manager liaises between study center personnel and the client, as appropriate, regarding clinical and/or technical issues, and tracks and reports data management status. In consort with managers within Clinical Data Management, the Senior Clinical Data Manager promotes consistent operations, efficient use of resources, and sharing of knowledge and best practices. The Senior Clinical Data Manager also promotes teamwork across functional groups.

Qualifications and Experience:

Minimum Education:

  • A BA or BS degree in a healthrelated field or Registered Nursing degree. Previous clinical data management experience may substitute for the post-secondary educational requirements.

Minimum Work Requirements:

  • A minimum of 7 years of directly related clinical data management experience and a minimum of 3 years of experience as a lead Clinical Data Manager.

Skills:

  • Overall understanding of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
  • Skilled in use of computer technology, including clinical trial database s and applications (e.g., ClinTrial, Inform) and ability to learn new applications.
  • Good understanding of project planning and management methods.
  • Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.

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© EuroJobsites 2019

EuroJobsites is a 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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