Connecting...

Data Manager - Standards Governance Advisor (m/w/d)

Location: Biberach, Baden-Württemberg Salary: Verhandelbar
Sector: Pharma & Biotech Type: Contract

Gesucht: Data Manager (m/w/d) - Standards Governance Advisor

Möchten Sie in einem spannenden Projekt arbeiten? Hier kommt Ihre Gelegenheit. Ich suche Sie als Data Manager (m/w/d).

Ihre Aufgaben als Data Manager - Standards Governance Advisor (m/w/d)

  • Implementation of meta data structures in STAMM (MDR) which are used to automate and control the clinical dataflow process for the multiple studies within each project
  • Maintenance of OC/RDC and/or RAVE global library questions, question groups, data collection modules and procedures
  • Translation of OC/RDC database into BRAVE database and corresponding SDTM mapping
  • Creation of study specific ALS files which will be uploaded into the RAVE system to create a study database
  • Evaluation, release and maintenance of new standard elements
  • Development and implementation of mappings from the different data structures (e.g. RAVE database, external lab data, external ECG data, etc. to SDTM data structures and development of corresponding training material.
  • Creation of data standards and set-up of mapping rules
  • Assess errors in the transformation program outputs to identify which area needs to be adapted (e.g. MDR, RAVE, SAS program) and perform corresponding correction
  • Define and maintain EDC global library elements, including eCRFs, fields, data dictionaries, and procedure specifications.
  • Define and/or approve trial database build specifications for implementation by database designers.
  • Periodically review the approved and used data standards
  • Review industry guidances and evaluate impact on BI data structures. Suggest implementation strategy and migration topics.
  • Set-up data standards and mapping rules.
  • Set up migration plans and mapping strategy for legacy projects.
  • DevelopoversightplansforexternalSDTMmapping

Ihr Profil

  • Bachelor's degree in Information Technology, Mathematics, Medical Documentation or Informatics or in a science related field.
  • Experience in Clinical Data Management, Data Standards or drug development in areas intersecting with Clinical Data Management
  • Detailed knowledge on CDISC models (main focus on CDASH and SDTM models) as well as familiarity with other data standards and models (e.g. ODM, ADaM, HL-7)
  • Good knowledge of the flow of data (structure and format) from patient to report and application of this knowledge to data standards development
  • Strong clinical knowledge and ability to liaise with trial- and project-teams
  • Required conceptual thinking in complex situations
  • Familiarity with clinical data standards tools and technologies
  • Proficient knowledge in programming in SAS and/or SQL
  • Excellentpresentationandcommunicationskills

Rahmendaten

  • Projektstart: 11.02.2019
  • Projektdauer: 24 Monate
  • Einsatzort: Biberach
  • Remote-Anteil: tbd

Interesse geweckt?

Wenn Ihnen die Stelle als Data Manager (m/w/d) zusagt, bewerben Sie sich so schnell wie möglich! Senden Sie Ihren Lebenslauf direkt über den Link auf der Webseite z.H. Frau Rebecca Brian.

Bitte geben Sie auch Ihre Verfügbarkeit, Ihre Stundensatzvorstellung und Referenzen an. Fragen zur Stelle beantworte ich gerne unter +49 (0) 69 264 89 8060.

Gerne können Sie die Stelle an interessierte Kolleg/innen weiterleiten. Neue Empfehlungen, die wir vermitteln können, belohnen wir mit einem Gutschein über 250 Euro von Amazon!

Ich freue mich auf Ihre Unterlagen und wünsche einen schönen Tag!