Clinical Systems Adminstrator

il y a 2 semaines

Paris, France Ividata Life Sciences Temps plein

The Clinical Systems Administrator is involved in the management and the maintenance of systems used by the clinical development & Biometry departments. These systems (eTMF VEEVA, SAS, Data Warehouse) can be used internally by teams and externally by several service providers (CROs).

in the context of different projects (systems upgrade, new systems implementation), the clinical systems administrator will:

- Produce/Review URS
- Participate in the system validation (review of risk analysis / produce validation scripts / execute validation scripts /review of executed scripts)
- Conduct UAT
- Develop/review Business admin guide
- Develop/review training material
- Update/develop new SOPs
- participate in the migration of studies into the new system
- participate in the decommissioning of the current solutions
- Participate in the archiving of data
- Answer to users’ questions
- Manage the system post golive : manage user access, system changes, users request

Education: Master’s degree in life sciences, information technology, or related field
Languages: Fluent English and French
**Experience**:

- Several years of experience in a similar position
- Good knowledge of systems used by clinical operations and DM department such as eTMF VEEVA, SAS, CTMS, CDMS
- Successful experience in the implementation of systems
- Good experience in IT project management, administration, and validation of IT systems
- Good experience in the development of training tools or in facilitating training sessions
- Good knowledge of the drug development process and clinical operations
- In-depth knowledge of international standards (ICH, GCP) and other regulatory and legal requirements having an impact on the development and maintenance of clinical operation systems
- Excellent oral and written communication skills.
- Ability to produce high quality, accurate work to meet deadlines.

Key Required Technical Competencies:

- Good knowledge of the clinical operation/Biometry systems eTMF VEEVA, SAS, CTMS, CDMS
- Good experience in validating GXP systems
- Good knowledge of project management methods
- Good knowledge of advanced Excel functions

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