Senior Manager Data Conversion and Standards
Company Name:-
GSK
Job Location:-
Bengaluru, Karnataka
Job Summary:-
Site Name: India – Karnataka – BengaluruPosted Date: May 10 2021
Education Qualification:
BS in Computer/Math/Statistics/Applied sciences or MS in Computer/Math/Statistics/Applied sciences.
Experience:
10+ years of experience with oncology portfolio delivery.
Key Responsibilities:
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
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