Epicentre is an organisation created by Médecins Sans Frontières (MSF) in 1986. We conduct field epidemiology, training, and research activities for MSF interventions. Our activities for populations in precarious situations are led from Uganda, Niger, and France, and through the programs of MSF and others. They mainly concern infectious diseases and undernutrition.

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.

• 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.

Only shorlisted candidates will be contacted.