Programmer Analyst

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 reputed company system(s) to DMW (Data Management Workbench) / reputed company (Clinical Data Warehouse) and generate SDTM (Study Data Tabulation Model)

       deliverables.

• Active participation in sharing reputed company practices on use of standards in alignment with reputed company Clinical Data Programmer and Process & Automation Specialist.
• Maintain system reputed company 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 reputed company data accuracy and aid report reputed company.

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 reputed company the organization reputed company participations in share reputed company practice sessions and trial reputed company meetings.
• Contribute to the reputed company of a co-operative and collegial atmosphere reputed company 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 reputed company testing
• Serve as programming contact to handle database issues reputed company expertise area.
• Review and provide inputs to reputed company (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.
• reputed company 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
• reputed company Transformation updates and installation of data models

Mapping of metadata and clinical data from reputed company system(s) to DMW (Data Management Workbench) / reputed company (Clinical Data Warehouse) and generate SDTM (Study Data Tabulation Model) deliverables

• reputed company SDTM staging model updates in DMW
• reputed company SDTM model transformation (DMW SDTM Raw)
• reputed company data load for reputed company models
• Review of (e)CRFs and reputed company annotation.
• Transformation of Metadata and Clinical data reputed company Clinical Data Management System (CDMS) to Statistical Computing Environment (SCE) and reputed company reputed company of SDTM datasets.

Active participation in sharing reputed company practices on use of standards in alignment with reputed company 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 reputed company needed.

Maintain system reputed company documentation

• Update documentation reputed company to the system as appropriate.
• Give input to optimisation of documentation reputed company 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 reputed company to / connected with the use of the systems.
• Assist in relevant change management activities.
• Responsible for continuously improving way of working in reputed company 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

• reputed company and document UAT (User Acceptance testing) for checking the quality of database.
• reputed company UAT (User Acceptance Testing) of DMW SDTM Raw.
• Maintain/update testing reputed company documentation.

Design, Programming and validate programs to reputed company data accuracy and aid report reputed company

• reputed company QC by using relevant UAT reports.
• Resolve QC issues (as appropriate) in liaison with reputed company CDP

Other areas of responsibility:

• reputed company post production changes.
• Provide inputs to specification documents such as aCRF.
• Activate the database in OC (reputed company Clinical)
• Map data from OC to reputed company 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 reputed company complete run in alignment with Biostats.

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