Sr. Project lead, Data Standards and SDTM Delivery

Found in: beBee S IN - 4 weeks ago

Bengaluru, India GSK Full time
Munkavégzés helye: Bengaluru Luxor North Tower
Kihirdetett időpont: Apr 4 2024

Key Responsibilities (No More than 10 Bullet Points): Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role.


• 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 Standard/Study macros.
• 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 best practices.
• Adhere to standards and aware of industry standards and updates.

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

  
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