Senior Data Manager – Germany

Excelya>Full-time>Senior Data Manager – Germany

Job description

Created in 2014, EXCELYA is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, EXCELYA advances scientific, managerial, and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

 

Job Summary

  • Key contact for client Data Management for any study responsible, ensure projects meet study timelines. Represent Data Management at Study Team meetings/client meetings
  • Support EDC database build and testing through go live
  • Drive, organize, monitors, and track ongoing data cleaning, data review, discrepancy management and data extractions for review committees, interims and database lock
  • Support eCRF design using CDASH and programming of SDTM output where required
  • Write, review, and approve study Data Management documents using agreed templates per EXCELYA Group SOPs or client SOPs
  • Manage external data including preparation of Data Transfer agreements, data reconciliation, loading, secure storage and archiving per client requirements
  • Ensure that data coding is performed in WHODrug or MedDRA versus client requirements
  • Review and generate study metrics and status reports within and across several studies
  • Vendor management and oversight of client service providers DM activities

We are currently implementing Veeva Clinical Data Management System – the newest leading edge Data Management system

Profile :

  • Higher education (BSc, MSc, PhD in life sciences or technical)

  • At least 3-5 years’ experience in data management in the pharmaceutical industry or CROs

  • Proficient in one of the leading Data Management systems: Veeva CDMS, Medidata RAVE, Oracle Inform/Clinical One or equivalent

  • Knowledge of clinical trials phase 1 through post marketing

  • Understanding of GCP and GDPR

  • Good level of German (mandatory) and English (written and oral)

  • Soft skills: Autonomy, teamwork, interpersonal skills, and leadership

  • Position based in Germany with some telecommuting.

 

To be filled ASAP

 

If you want to join an attractive CRO which develops and retains talents, do not hesitate to send us your full application including salary expectation and earliest possible date of joining!

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