Senior Clinical Data Manager

Highly Competitive
  1. Permanent
  2. Data Management
  3. Germany
Germany
Posting date: 23 Jun 2020
30166

A home-based vacancy for a Senior Clinical Data Manager has arisen in Germany. This organisation is committed to making exceptional, innovative biopharmaceuticals improvements to the lives of patients suffering from serious diseases.


Job Responsibilities

  • Provide clinical data management support to the clinical trial teams (CTT)
  • Participate in the review of the clinical trial documents
  • Oversee the development and implementation (including change management) of clinical data management activities outsourced to the vendor in a clinical trial 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
  • 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
  • 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 and/or coding in agreement with all regulatory requirements
  • Author of the Data Management related SOPs and responsible for the period update of these SOPs

Skills and Requirements

  • Successfully completed professional training (Master's Degree or equivalent) in the field of data management or related subject
  • At least 5-8 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
  • Experience in handling study migrations
  • Good understanding of global clinical trial practices, procedures and methodologies
  • Experience with database decommissioning and archiving process
  • Ability to prepare data for biostatistical analyses
  • Knowledge of CDISC / CDASH / SDTM standards
  • Excellent organizational and time management skills

To Apply

In case you have difficulty in applying or if you have any questions, please contact Heidi Hennigan on 44 2038541033 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies

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