Key responsibilities:
- Design and set-up of study database for data collection in clinical trials based on protocol needs
- Set up of models and performing transformation updates in DMW
- Mapping of metadata and clinical data from source system(s) to DMW (Data Management Workbench) / CDW (Clinical Data Warehouse) and generate SDTM (Study Data Tabulation Model)
deliverables.
- Active participation in sharing better practices on use of standards in alignment with Lead Clinical Data Programmer and Process & Automation Specialist.
- Maintain system related documentation.
- Facilitate implementation of business processes introduced by the systems supported by DaMaSys (Data Management Systems & Standards).
- Ensure testing is performed and database meets specification requirements before deployed into production and document pass and fail scenarios in a timely manner.
- Design, Programming and validate programs to check data accuracy and aid report generation.
General responsibilities
- Be compliant on SOPs, GCP, GDP and GPP (good programming practice).
- Collaborate with trial teams to agree/negotiate on timelines.
- Promote the exchange of know-how within the organization via participations in share better practice sessions and trial related meetings.
- Contribute to the generation of a co-operative and collegial atmosphere within the department.
- Report regular status updates to Manager.
Design and set-up of study database for data collection in clinical trials based on protocol needs
- Create trial in CDMS (Clinical Data Management System), set up trial database and activate the database upon approval from relevant stakeholders.
- Apply or copy global validation/derivation checks, build trial specific checks and perform testing
- Serve as programming contact to handle database issues within expertise area.
- Review and provide inputs to EDC (Electronic Data Capture) requirements in relation but not limited to protocol, flow chart, SDTM domains etc.
- Review and provide inputs to Project plan, Blinding Plan, and any other documents based on trial and process requirement.
- Perform blinding of data points during database set-up as required by Blinding Plan/Blinding Implementation document.
- Create and maintain relevant documents as per TMF's (Trial Master File) ToC (Table of Contents).
Set up of models and performing transformation updates in DMW
- Create trial in DMW, apply template and set up DMW Inform model
- Create DMW mapping specification and external data specification
- Update filewatcher configuration for external data models
- Perform Transformation updates and installation of data models
Mapping of metadata and clinical data from source system(s) to DMW (Data Management Workbench) / CDW (Clinical Data Warehouse) and generate SDTM (Study Data Tabulation Model) deliverables
- Perform SDTM staging model updates in DMW
- Perform SDTM model transformation (DMW SDTM Raw)
- Perform data load for all models
- Review of (e)CRFs and DCM annotation.
- Transformation of Metadata and Clinical data within Clinical Data Management System (CDMS) to Statistical Computing Environment (SCE) and enable generation of SDTM datasets.
Active participation in sharing better practices on use of standards in alignment with Lead Clinical Da-ta Programmer and Process & Automation Specialist
- Share trial learnings along with impact analysis with line manager and team.
- Ensure the learnings are implemented to forthcoming trials / projects.
- Ensure that the newest knowledge is collected and shared with relevant stakeholders including super users in Clinical & Data Science on database set-up and SDTM activities
- Support communication around methods and standards in Clinical & Data Science
- Give input to internal workshops and seminars.
- Advise and assist co-workers when needed.
Maintain system related documentation
- Update documentation related to the system as appropriate.
- Give input to optimisation of documentation related to the system.
Facilitate implementation of business processes introduced by the systems supported by DaMaSys (Data Management Systems & Standards)
- Give input to optimisation of processes related to / connected with the use of the systems.
- Assist in relevant change management activities.
- Responsible for continuously improving way of working in close collaboration with the other departments in Data Management Systems & Standards and their stakeholders.
- Facilitate update to relevant processes and documents.
- Be enablers of timely and fit-for-purpose products.
Ensure testing is performed and database meets specification requirements before deployed into production and document pass and fail scenarios in a timely manner
- Perform and document UAT (User Acceptance testing) for checking the quality of database.
- Perform UAT (User Acceptance Testing) of DMW SDTM Raw.
- Maintain/update testing related documentation.
Design, Programming and validate programs to check data accuracy and aid report generation
- Perform QC by using relevant UAT reports.
- Resolve QC issues (as appropriate) in liaison with Lead CDP
Other areas of responsibility:
- Perform post production changes.
- Provide inputs to specification documents such as aCRF.
- Activate the database in OC (Oracle Clinical)
- Map data from OC to CDW ensuring consistency and correctness according to the SDTM data model / domains.
- Create aCRF, define.xml. and SDRG (Study Data Reviewer’s Guide).
- Finalize SDTM package and perform complete run in alignment with Biostats.
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