Sr. Project lead, Data Standards and SDTM Delivery

1 month ago

Bengaluru, India GSK Full time
Nama Site: Bengaluru Luxor North Tower
Tanggal Posting: 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.

Tujuan kami adalah menjadi salah satu perusahaan perawatan kesehatan yang paling inovatif, berkinerja terbaik, dan tepercaya di dunia. Kami meyakini bahwa kami semua membawa sesuatu yang unik ke GSK, dan dengan memadukan pengetahuan, pengalaman, dan gaya kami, dampaknya akan luar biasa. Bergabunglah dengan petualangan kami di GSK, di mana Anda akan terinspirasi untuk melakukan yang terbaik bagi pasien dan konsumen kita. Tempat di mana Anda menjadi diri sendiri, merasa baik, dan terus berkembang.

  

Pemberitahuan penting kepada Bisnis/Agen ketenagakerjaan

GSK tidak menerima rujukan dari bisnis ketenagakerjaan dan/atau agen ketenagakerjaan dalam kaitannya dengan lowongan yang diposting di situs ini. Semua bisnis/agen ketenagakerjaan harus menghubungi departemen pengadaan komersial dan umum/sumber daya manusia GSK untuk memperoleh otorisasi tertulis sebelum merujuk kandidat ke GSK. Mendapatkan otorisasi tertulis sebelumnya merupakan prasyarat sebelum perjanjian apa pun (lisan atau tertulis) antara bisnis/agen ketenagakerjaan dan GSK. Jika otorisasi tertulis tersebut tidak diperoleh, maka tindakan apa pun yang dilakukan oleh bisnis/agen ketenagakerjaan akan dianggap telah dilakukan tanpa persetujuan atau perjanjian kontrak dengan GSK. Dengan demikian GSK tidak bertanggung jawab atas biaya apa pun yang ditimbulkan oleh tindakan tersebut atau biaya apa pun yang ditimbulkan oleh rujukan apa pun oleh bisnis/agen ketenagakerjaan dalam kaitannya dengan lowongan yang diposting di situs ini.

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