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May 252018
 

Organization: Epicentre
Country: France
Closing date: 17 Jun 2018

Epicentre is a non-profit organization created in 1986 by Médecins Sans Frontières, whose activities include research, field epidemiology and training. Epicentre is a World Health Organization Collaborating Centre for Research in Epidemiology and Response to Emerging Diseases. Epicentre follows its activities from Paris, Geneva, Brussels, Barcelona, New-York and from research centres in Uganda and Niger.

This position will cover activities related to the data management of an international multicentric randomized therapeutic trial (END-TB for Evaluating New Drugs for multidrug-resistant TB) to evaluate short oral drug regimens for treatment of multidrug resistant tuberculosis in a pragmatic adaptive design. The trial is a collaborative project between Partners In Health (PIH, Boston USA), Médecins Sans Frontières (MSF, Paris, France and Geneva, Switzerland), the Institute of Tropical Medicine (ITM, Antwerp, Belgium) and Epicentre (Paris, France) and is funded by UNITAID.

Position

The Data Manager will work in close collaboration with the statistician, providing data management support and will collaborate with the teams from other consortium organizations.

Main Activities

  • Participate in the review of clinical research documents (protocols, amendments, CRF…);
  • Update the data management plan and ensure it is followed;
  • Update the documentation related to the clinical database specifications, including user requirements, edit rules/checks, queries and data validations;
  • Annotate the CRF;
  • Update the OpenClinica database;
  • Maintain/track the database users management;
  • Train the database users and update user guides;
  • Maintain close relationships with the data entry team on the different sites;
  • Support data entry teams to solve any technical problems;
  • Ensure quality of the data entered in the database for statistical review, interim analyses, and database lock;
  • Ensure data extraction following specifications for different needs (analyses, data reconciliation);
  • Assist in data reconciliation with the safety database, laboratories data and external data;
  • Assist in preparing data listings;
  • Develop and maintain the data management report;
  • Coordinate the archiving of study databases and related documents.

Candidate requirement

  • Degree or diploma in Data Management (MSc of equivalent)
  • Working experience of at least 2 years as clinical data manager, preferably with international/multi-sites experience
  • Working knowledge of clinical database applications such as EDC and CTMS, in particular with OpenClinca
  • Working knowledge of statistical software as Stata
  • Knowledge of CDISC standards
  • Good knowledge of the Good Clinical Practices and the International Code of Harmonization Guidelines
  • Fluent in English
  • Good organizational and team skills

Conditions

  • Position based in Epicentre, Paris, with work travels

  • Short-term Contract: 18 months starting September 2018

  • Remuneration: 47K€ on 13 months; 22 extra days-off, health insurance, reimbursement 50% of public transport title, meal voucher.

How to apply:

Please apply online before June, 17th 2018: http://epicentre.msf.org/recrutement.

Only shorlisted candidates will be contacted.

If you encounter technical issues to apply, please contact: recrutement@epicentre.msf.org.

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