GSK - Manager - Data Conversion & Standards

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

- Perform other duties assigned by the Respective Manager / Department Head

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