GSK

Manager - Data Conversion and Standards

2 months agoBengaluru, India

Site Name: India - Karnataka - Bengaluru
Posted Date: Jun 21 2021

Minimum Education Qualification:

BS in Computer/Math/Statistics/Applied sciences BS in Computer/Math/Statistics/Applied sciences or MS in Computer/Math/Statistics/Applied sciences .

Experience:

6 plus years of programming experience

Key Responsibilities:

  • Provide innovative solutions, developing and delivering quality data conversion process as well as ensure operational delivery for oncology portfolio.
  • Responsible for the development, validation and review of study & standard programs/macros (Including SAS, PL/SQL.SPOTFIRE, R-Programming, Python) that support standard and study-level conversion of clinical trial data.
  • Responsible for review development and validation of CDASH and SDTM Mapping to support management of data standards and studies.
  • Responsible for the review, development of aCRF, SDRG, Pinnacle 21 annotation and definexml for various standard or specific studies.
  • Lead the Requirement gathering, development of specifications, Validation plans and performing end to end validation of Standard/Study macros.
  • For complex programs & tools, oversee & coordinate a group of Programming Leads in a matrix setting
  • Support the programmers in trouble shooting and debugging of complex standard and study programs/macros.
  • Adhere to the relevant departmental SOPs, corporate policies, regulatory requirements and industry best practices.
  • Act as a technical owner and/or reviewer/ultimate approver for tools and programs developed in SDTM Programming group.
  • Provide support for implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections
  • Establish and maintain effective working relationships with partners and stakeholders.
  • Act as a coach & mentor for members of the team.
  • Adhere to standards and aware of industry standards and updates.
  • Expert in defensive programming techniques.
  • Extensive knowledge of drug development process and working knowledge of GxP.
  • Knowledge on regulatory submissions (JPMA/PMDA) and hands-on knowledge on programming data conversions.
  • Has good communication skills and ability to effectively inform stakeholders of progress and challenges with deliverables.
  • Ability to have FSP oversight.
  • Able to conduct technical interview part of an interview panel.
  • Experience performing data conversion on large phase 3 oncology studies.
  • Experience converting structured and unstructured data from various sources including RAVE/InForm/Veeva as per GSK standards.
  • Experience with CRF automation process for SDTM annotations.
  • Experience review and co-ordination of SDTM review on outsourced studies.
  • Experience understanding SDTM harmonization for pooled analysis.
  • Contributes to GSKs compliance to external data standards mandates and reviews industry data standards proposals/changes and provisions feedback.
  • Conducts risk analysis for internalization of industry standards and changes to those standards.
  • Develops standards in-line with business demand e.g. CDISC SDTM dataset, Controlled Terminology (CT), Value level definition and metadata (VLD/VLM)
  • Ability to perform the final review
  • Excellent in Project Management for end to end study . Experience in handling end to end studies (CDMTo Submission) from the Project Management will be added advantage
  • Experience in collecting the Project Management Reports
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