Senior Clinical Data Manager

Position: Senior Clinical Data Manager
Department: Statistics, Data Management, Medical Writing
Responsible to: Head of Statistics, Data Management, Medical Writing
Location: Prague, Czech Republic
Employment type: Full time employment

Position Summary:

The Senior Clinical Data Manager provides expertise in all data management activities related to the preparation and implementation of clinical trials in the EU, US and elsewhere. Works closely with colleagues in Biostatistics, Clinical Development, Development Operations, Pharmacovigilance, Regulatory Affairs, and other related disciplines to support database development and reporting for all clinical studies.

Key Activities and Responsibilities:

  • Provide oversight/management (of CRO's) and participate in study set-up and initiation procedures such as eCRF design, database design, edit check design/review, and DMP (data management plan) review.
  • Ensure the proper collection, management, and storage of clinical trial data (according to regulatory requirements).
  • Ensure proper clinical data review and query management.
  • Drive development of data management guidelines and quality processes to ensure final databases are accurate.
  • Specify / perform data validation and quality checks, and initiates corrective and preventive actions as indicated.
  • Specify / run standard and custom reports (in Medidata Rave or other EDC systems) to support Clinical Operations and Development.
  • Manage development and implementation of company data standards; ensure implementation of CDISC-SDTM as appropriate
  • Manage and coordinate vendors with regard to data management tasks, ensure timely delivery of agreed items. 
  • Participate in other activities and meetings to support Biostatistics, Clinical Operations, and the Development Team as needed.
  • Perform these tasks with a high level of independence and proactivity.

Competences, Skills and Qualification:

Minimum Qualifications:

  • 5 years of clinical trial data management in the pharma/biotech industry.
  • Bachelor’s degree in medical, scientific, biological, statistical, computer science, or related field.
  • Fluent English.
  • Experience in clinical trials through Phase 3 (NDA submission).
  • Data management experience using Medidata Rave EDC system / INFORM / Other EDC systems, reporting capabilities.
  • Proficiency with Microsoft Office (Excel, Word, PowerPoint, and Outlook).
  • Familiarity with ICH GCP as well as general knowledge of industry practices and standards such as CDISC-SDTM data standardization specifications.
  • Ability to anticipate and timely escalate issues and to define appropriate action plans.
  • Strong vendor management skills.
  • Good communication skills, creativity, ability to identify a need for new processes.

Preferred Qualifications:

  • Master degree or higher.
  • SAS Programming experience.
  • Experience working with safety data and coding dictionaries (MedDRA and WHODRL).
  • Experience in the design and management of clinical trial databases using Medidata Rave / INFORM / Other EDC system.
  • Experience setting up and/or utilizing standardized “global library” for CRFs.

Contact us

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