GSK - Senior Manager - Data Conversion & Standards (10-15 yrs)
Site Name: India - Karnataka - Bengaluru
BS in Computer/Math/Statistics/Applied sciences or MS in Computer/Math/Statistics/Applied sciences.
10+ years of experience with oncology portfolio delivery.
- Provide innovative solutions, developing and delivering quality data conversion process as well as ensure operational delivery for oncology portfolio.
- Accountable and responsible for quality, cost and consistency of SDTM delivery for in-house across TA.
- High competence in data conversion as per industry standards. Especially around SDTM delivery.
- Knowledge on regulatory submissions including (JPMA/PMDA) and hands-on knowledge on programming data conversions.
- Able to lead the planning of multiple deliverables and priorities for the team.
- Able to articulate and explain technical concepts and standards related concepts to the cross-functional teams.
- Able to identify data compliancy and data integrity issues ahead of time and raise the risk to senior management.
- Experience providing input to CAPA and response to audit findings.
- Has good communication skills and ability to effectively inform stakeholders of progress and challenges with deliverables.
- Ability to manage FSP programmers and review the work done by FSP teams.
- Experience managing and co-ordinating SDTM quality review of GSK outsourced studies.
- Able to mentor and coach junior team members.
- Experience conducting technical interviews for recruitment process.
- Able to present in conferences and collaborate with other industry team members to understand industry trend.
- Able to delegate tasks to other team members and oversee the quality and decisions made by the team members.
- Experience performing data conversion on large phase 3 oncology studies.
- Ability to identify areas to implement automation to increase efficiencies.
- Taking the lead to develop new process and guidelines for the team.
- Experience strategizing conversion using RAVE/InForm/Veeva as well as incorporating variety of structured and unstructured external study data.
- Experience leading the team through CRF automation, metadata automation and conversion automation process.
- Ability to lead and provide direction on standards content for building the repository.
- Conducts risk analysis for internalization of industry standards and changes to those standards
- Acts as a standards champion across GSK to develop and support stakeholders awareness and uptake
- Provides standards consultancy to business functions on demand
- Contributes to development of standards related documentation, e.g., SOPs, Guidance Documents, technical guidelines
- May be asked to sit on intra/extra GSK external teams
- Experience implementing KPI
Our goal is to be one of the worlds most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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