Clinical Data Manager

Hobson Prior are looking for a Clinical Data Manager to join a non-profit organisation who focus on providing pioneering antimalarial drugs. As the Clinical Data Manager, you will centralize the organisations data from all clinical trials to facilitate access for scientific analysis and regulatory submissions and long-term storage.

Job Responsibilities:

• Contribute to the strategy, selection, management and integration of a centralized CDISC Study Data Tabulation Model format clinical data repository at the organisation, including selection and management of repository provider and technology.
• Upload documents and data of historical clinical trials into the centralized repository.
• Communicate with current data holders to transfer the data to the centralized repository.
• 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.
• Complete a quality check of the data received and/or transferred to the repository.
• Provide access of the repository to the organisation's 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.
• Convert data to the agreed CDISC SDTM format if necessary.

Key Skills:

• 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).

Requirements:

• 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
• 3-4 years of experience in a multinational/ international environment.
• Prior experience in the pharmaceutical industry is an asset.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.