Wir haben zum nächstmöglichen Zeitpunkt folgende Position zu besetzen:

Clinical Data Manager (gn)

Ihre Verantwortungsbereiche:

  • Provide clinical data management support to the clinical trial teams (CTT)
  • Participate in the review of the clinical trial documents (e.g. protocols, case report forms and statistical analysis)
  • Participate in the selection process of appropriate vendors for outsourcing data management related activities
  • Oversee the development and implementation (including change management) of clinical data management activities outsourced to the vendor in a clinical trial (i.e. Data Management Plan, eCRF, Database Specification, Data Transfer Plan, UAT Test Scripts and Execution Logs, integration of historical control data, etc.) to ensure quality and adherence to the timelines
  • Participate in meetings with vendors to review project plans and timelines, address and resolve data related issues identified in the trial and requests from the CTT
  • Coordinate the UAT of eCRF build and validation documents including but not limited to edit check document, issue logs, UAT summary report with the vendor; ensure CRF preparation as per CDISC standards
  • Participate in the definition and implementation of eCRF standards
  • Keep an oversight of data cleaning, data mapping and SDTM data transfer for assigned projects
  • Ensure reconciling of SAE data in Safety Database and Clinical Database by the vendor
  • Support in defining and quality control of data listings, summary table validation, data specifications and/or process data transfers by the vendor in preparation for statistical review
  • Ensure implementation of all data processing quality steps as per applicable SOPs
  • Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock - included but not limited to data reconciliation andor coding in agreement with all regulatory requirements
  • Coordinate the archiving of study databases and related documents
  • Create and update the Data Management related SOPs

Sie bringen idealerweise folgende Voraussetzungen mit:

  • Successfully completed professional training (Master's Degree or equivalent) in the field of data management
  • At least 5 years of data management and/or related work experience in pharmaceutical industry
  • Experience with EDC systems like ORACLE, InForm or Medidata Rave
  • Experience in (e)CRF design and programming
  • Experiences with other data management relevant systems, such as IVR systems and CDMS
  • SAS or ,,R" experience
  • Experience in defining standards for data import/export into/from clinical databases
  • Ability to coordinate data management activities with external vendors
  • Good understanding of global clinical trial practices, procedures and methodologies (such as ICH-GCP and 21 CFR part 11)
  • Experience with database decommissioning and archiving process
  • Ability to prepare data for biostatistical analyses
  • Knowledge of CDISC / CDASH / SDTM standards
  • Knowledge of WHO Drug and MedDRA dictionary
  • Excellent organizational and time management skills
  • Team player with well-developed interpersonal abilities
  • Good written and oral communication skills in English

Wir bieten Ihnen:

  • Kreatives Arbeiten in X-functional Teams
  • Offene und wertschätzende Unternehmenskultur
  • Multikulturelles Umfeld
  • Arbeiten in einem attraktiven, hochwertig ausgestatteten Gebäude mit Betriebsrestaurant
  • Kostenfreie Sportangebote und Sprachkurse
Über Ihr Interesse und auf Ihre aussage­kräftigen Unter­lagen freuen wir uns! Bitte be­wer­ben Sie sich direkt über unser Karriere­portal www.morphosys.de/karriere. Wir bieten Ihnen nicht nur aus­ge­zeichnete Ent­wicklungs­möglich­keiten, sondern unter­stützen Sie von Anfang an - auch bei Ihrem Umzug.
MorphoSys AG, Semmelweisstraße 7, 82152 Planegg
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