Merck KGaA

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Originele vacaturetekst

Senior Data Standards Expert (all genders)

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:

An exciting opportunity has arisen to join our healthcare business to support the development of first and best in class specialty medicines for our patients in need. As a Senior Clinical Data Standard Expert with in-depth CDISC-SDTM knowledge you will ensure Quality of Data Standards and Data Formats for submission of Data to Health Authorities. The review of CRO and other internal or external third parties deliveries (Data Quality, Data Formats, Timelines), identifying and resolving issues with partners will be in your responsibility scope. In close collaboration with trial and project teams you will ensure CRO and data quality surveillance by designing, developing and supporting Data Quality surveillance processes and tools.

Who you are:

  • Advanced degree in Life Sciences, Mathematics, Computer Sciences or comparable
  • Excellent CDISC expertise (SDTM and Controlled Terminology) and expertise in Clinical Data Standards
  • Proven experience as a Data Standards Expert or related Data Management expertise in the pharmaceutical/biotechnology industry, equivalent to 8 years
  • Extensive knowledge of CDISC SDTM, define.xml and comprehensive knowledge of CDISC CDASH (knowledge of ODM-XML and ADaM is a plus)
  • Extensive knowledge in Data Standards Development as well as in Data Standard Tools (knowledge of Pinnacle 21 enterprise and Formedix is a plus)
  • Comprehensive knowledge and previous experience in oncology (data standards/clinical studies)
  • SAS and R programming expertise is a plus
  • Comprehensive knowledge of ICH-GCP and major health authorities (e.g. FDA, EMA, CFDA, PMDA) regulations
  • Experience as Clinical Data Manager

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Art des Stellenangebotes:
Intern

Fähigkeiten

  • Es ist kein Abschluss erforderlich