Principal Clinical Database Programmer
3 days ago
Tech Observer is a Global CRO and FSP solution provider with HO in NJ, USA and presence in other 20+ countries. Tech Observer is an equal opportunity employer.
Job Location : Mumbai/Ahmedabad/Hyderabad
Brief Responsibilities ( but not limited to)
• Responsible for efficient planning, designing ,development and maintenance of clinical
database management systems and associated modules.
• Creation and maintenance of Global library.
• Responsible for preparation and review documentation of clinical trial database
maintenance/design activities.
• Assist HOD and stake holders in evaluation an selecting of new software.
• Responsible for end to end Programming activities which includes Designing CRFs, Edit
Checks programming, Custom function, Dynamics and Derivations.
• ALS Draft Upload: Performing Overwrite, Draft Merge and New Draft Creation. Download
CRF draft, template settings and upload CRF draft settings.
• Migrations (PPC): Performing impact analysis, Amendment Manager, Creation and Execute
plan, Run Difference Report, Run Migration, and Publish Checks.
• Cloud Admin: Creating Sites, creating users, providing EDC access, Creating environments
(Dev, UAT, Prod, MIG, etc.)
• Assist in data validation, lab data load and data transfers according to client specifications.
• Assist onboarding of new software /systems and communication with internal /external
stakeholders for issues resolution.
• Assist in process improvement/ mentoring programmers.
Preparation and QC of aCRF and Metadata and eCRF specifications.
• Reporting and resolution of error in systems used in Tech Observer.
• Team management: Managing resources and activity allocation.
• Other responsibilities as delegated by reporting head or Management.
• Ensure compliance to applicable rules, regulations, guidelines, standard operating
procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.
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