Sr. Project lead, SDTM & Programming
Job ID 50471
Experience 6 Years
• 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.
• 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.
• Leads the Requirement gathering, development of specifications, validation plans and performing end to end validation of
• Implements defensive programming techniques as a part of development lifecycle management of macros/programs/tools.
• Project Manages end to end study and ensures deliverables are met on time.
• Handles end to end studies (CDM (Clinical Data Management) To Submission).
• Support 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.
• For complex programs & tools, oversee & coordinate a group of Programming in a matrix setting.
• Establish and maintain effective working relationships with partners and stakeholders while assisting them through progress and
challenges with deliverables.
• Adhere to the relevant departmental SOPs (Standard Operating Procedures), corporate policies, regulatory requirements, and industry
• Adhere to standards and aware of industry standards and updates.