Data Management Senior Officer – Bilingual at Drugs for Neglected Diseases initiative – DNDi

Drugs for Neglected Diseases initiative (DNDi) is an independent, not-for-profit drug development initiative established in 2003 by five publicly-funded research organizations – Malaysian Ministry of Health, Kenya Medical Research Institute, Indian Council of Medical Research, Oswaldo Cruz Foundation Brazil, and the Institut Pasteur – as well as an international humanitarian organization, Médecins Sans Frontières. The UNICEF/UNDP/World Bank/WHO’s Special Programme for Research and Training in Tropical Diseases (TDR) is a permanent observer. With a robust portfolio, DNDi aims to develop new, improved, and field-relevant drugs for neglected diseases, including leishmaniasis, human African trypanosomiasis (sleeping sickness), Chagas disease, malaria, filarial diseases, paediatric HIV, mycetoma, and hepatitis C that afflict the poorest populations of the world.

Purpose of the position

This position will coordinate data entry and other data management activities providing Data Management and Biostatistics support through designing, setting up of data management systems, and validating databases for clinical studies and in the preparation of the necessary clinical data related documentation.

Specific job responsibilities

  • Assist in setting up data management systems for the DNDi Data Management and Biostatistics department, together with the implementation, review, and monitoring of the systems
  • Design, set up, and validate databases and data entry screens for clinical research projects, and prepare the necessary documentation
  • Develop, write, test, and validate inbuilt data inconsistency checks
  • Ensure that data queries are raised and resolved in a timely and accurate manner
  • Ensure data management quality control procedures are done in a timely and accurate manner
  • Provide feedback and training to study teams regarding common data errors
  • Supervise, train data management officers and data entry staff
  • Take lead in Case Report Form (CRF) development
  • Contribute to the development of SOPs for the data team, in compliance with Good Clinical Practice (GCP)
  • Coordinate data entry and other data management activities both at trial sites and the Data Management and Biostatistics department (including Electronic Data Capture)
  • Assist in developing effective systems and procedures for ensuring an efficient and reliable data management service in DNDi Data Management and Biostatistics department
  • Participate in efforts geared towards improving the effectiveness and efficiency of operations in accordance with the policies and procedures as laid down in the organization’s quality manual

Reporting line

  • S/he reports to the Data Operations Manager
  • Close working relationship with the relevant members of the DNDi East Africa regional office in Nairobi and DNDi global disease teams

Job requirements

Skills and attributes

  • Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines.
  • Clear and systematic thinking that demonstrates good judgment and problem-solving competencies.
  • Very good communication skills in multicultural, multi-lingual environments
  • Ability to work effectively as part of a multicultural team
  • Well organized and structured
  • Very good analytical skills
  • Ability to contribute to the project delivery under minimum supervision
  • Ability to manage middle sized projects with budget management under supervision
  • Provide specialist services to operational line or project team
  • Ability to solve non-routine problems on a case by case/project basis
  • Has certain autonomy for taking actions and decisions
  • Ability to interact with external stakeholders
  • Ability to be the focal point/manager for consultants
  • Ability to supervise at a smaller level

Experience

  • Minimum 6 years’ relevant experience with at least 3 years data management experience in a clinical research environment
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience working with Electronic Data Capture (EDC) systems

Education

  • Graduate or post graduate degree in computer science/ICT/IT or relevant field

Other requirements

  • Fluency in English and French
  • Travel up to 25%

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