Data Manager, Translational Medicine

Geneva, Switzerland | Translational Team | Full-time

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MMV is a leading product development partnership (PDP) in antimalarial drug research and is in its 20th year. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs.  Since its founding in 1999, MMV and partners have brought forward 12 new medicines that have saved an estimated 1.9 million lives. 

We are currently seeking a Data Manager, Translational Medicine to join our Translational team for a 3-year period. Reporting to the VP, Head of Translational Medicine, the successful candidate will help define the strategy for clinical data management fit for MMV purpose, ensuring its implementation and further development.

The Data Manager will centralize MMV data from all clinical trials to facilitate access for scientific analysis and regulatory submissions and long-term storage. In addition, he/she will help the Pharmacometrics team to convert the data into the appropriate format for their Physiologically Based Pharmacokinetics (PBPK) / Pharmacokinetics-Pharmacodynamics (PKPD) analysis, to manage and share the modelling files within the team, across MMV as well as with external modellers.

Primary duties and responsibilities:

  • Contribute to the strategy, selection, management and integration of a centralized CDISC Study Data Tabulation Model (SDTM) format clinical data repository at MMV, including selection and management of repository provider and technology
  • Upload documents and data of historical clinical trials into the centralized repository:
    -Liaise with current data holders to transfer the data to the centralized repository
    -Convert data to the agreed CDISC SDTM format if necessary
  • Upload documents and data of ongoing and future clinical trials into the centralized repository:
    -Liaise with external vendors to define the CDISC SDTM format required and data exchange processes and to ensure a smooth transfer of the data at the end of the clinical trial
    -Perform a quality check of the data received and/or transferred to the repository
  • Provide access of the repository to MMV scientists and authorized external partners for upload or download of documents or data as appropriate
  • Retrieve and tabulate necessary data in a regulatory-compliant manner to help scientific analysis (i.e. analysis of PKPD data or validation of PBPK models)
  • Work with Clinical Development and Translational Medicine teams to review the evolving needs for the centralized repository of data, identify improvement opportunities, suggest and implement improvement plans, monitor outcomes
  • Work with the Pharmacometrics team to develop and manage a tool to help them keep track of their modelling activities; share the input and output files between members of the team and external modelling consultants and disseminate the modelling results across the Research and Development Department

Education and experience:

  • University Degree or major in either:
    - Science (Biology, Chemistry or a related Natural or Biological science) with an interest in IT
    - IT with an interest in chemical and biological sciences
  • Three to four years of experience in a multinational/ international environment
  • Previous experience in the pharmaceutical industry is an asset

Technical skills required:

  • Excellent command of English (both oral and written), good command of French desirable
  • Comprehensive knowledge of clinical trial design; understanding of the overall drug development process
  • Experience in project management activities
  • Knowledge of international clinical research regulations and requirements (e.g. ICH/GCP)
  • Expertise with all Microsoft applications
  • Knowledge of CDISC Standard for Exchange of Nonclinical Data (SEND) format would be an asset
  • Knowledge of statistical computing and graphics tool would be considered a plus
  • Basic knowledge in malaria drug development or other neglected diseases would be considered a plus

Behavioural skills required:

  • Willingness to help and support others
  • Autonomous and proactive – able to work independently under minimal supervision
  • Excellent organisational skills and time management
  • Strong communication skills, both verbally and in writing
  • Ability to coordinate and deliver multiple activities
  • Cultural awareness and sensitivity – need to work with diverse international teams
  • Flexibility and ability to handle frequent changes

 Start date: As soon as possible

Interested applicants should send their CV and a cover letter giving reasons for their interest in the position.