Data Standards and SDTM Delivery Lead

4 weeks ago


Bengaluru, Karnataka, India ScaleneWorks Full time
Key Responsibilities

Development and Validation: Involves in the development, validation, and review of study & standard programs/macros (including SAS, CQL, PL/SQL, SPOTFIRE, R-Programming, Python) that support standard and study-level conversion of clinical trial data.

SDTM Mapping and Review

Responsible for the review, development, and validation of SDTM mapping, aCRF, SDRG (Study Data Reviewers Guide), Pinnacle 21, define.xml, data Listings and checks for various standard or specific studies.

Project Management and Delivery

Leads the requirement gathering, development of specifications, validation plans, and performing end-to-end validation of standard/study macros. Project manages end-to-end study and ensures deliverables are met on time.

Troubleshooting and Technical Support

Supports the programmers in troubleshooting and debugging of complex standard and study programs/macros. Acts as a technical owner and/or reviewer/approver for tools and programs developed in the group.

Team Leadership and Collaboration

Oversees and coordinates a group of programmers in a matrix setting for complex programs & tools. Establishes and maintains effective working relationships with partners and stakeholders while assisting them through progress and challenges with deliverables.

Adherence to Standards and Regulations

Adheres to the relevant departmental SOPs (Standard Operating Procedures), corporate policies, regulatory requirements, and industry best practices. Adheres to standards and aware of industry standards and updates.



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