Clinical Data Manager/SAS Programmer
Posted on Jun 3, 2022 by Actalent
The Clinical Data Manager & SAS Programmer role provides Data Management and SAS Programming support as part of the biometry team to ensure high quality data through the clinical studies life cycle.
Clinical data management:
- Responsible, with limited direction, for planning and executing clinical data management activities in clinical studies or projects ensuring that deliverables are met in timelines and quality
- Develop, document, and maintain data management study related documentation (eg data management plan, data management report)-
- Generate and manage the data queries (including inconsistent, missing and incorrect data) generated by the electronic data capture systems-
- Develop ad-hoc SAS program for edit checks outside the electronic data capture systems
- Generate ad-hoc reports for the clinical project team (eg monitors, clinical project manager, etc.)
- Oversee data review activities within the clinical database:
- Coordinate database lock procedures, including all QC efforts, in-line with database lock requirements
- Ensures that all activities under responsibility are properly documented (traceability of changes, data specifications) according to the internal guidance documents
- Developing ad-hoc SAS programs according to clinical project needs: eg utilities for data cleaning, handling of external data, import/reconciliation of internal/external data, pooling of database, programming of ad-hoc reports (patients profile, data review report, clinical metrics reports), etc.
- Performing quality control on SAS programs/outputs created by another SAS programmer
- Developing and/or validating ad-hoc SAS macros
- Reviewing SDTM datasets specification developed by an external vendor; using CDISC guidelines to generate SDTM/ADaM datasets
- Exhibits routine and complex problem solving skills
- Ensures that deadlines are met
- Encourages and maintains quality in the data management activities
- Collaborates effectively with the biometry and clinical project teams
- Works according to ICH-GCP, other international guidelines (eg, ISO), working group recommendations (eg, CDISC or Good Clinical Data Management Practices, Good Programming Practices) as well as internal quality systems
- Performs other tasks as per line management discretion
If this looks like something you'd be interested in applying for, please send your most up to date CV to (see below)
Job Title: Clinical Data Manager/SAS Programmer
Location: Paris, France
Rate/Salary: .00 EUR Yearly
Job Type: Permanent
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