Associate Director Data Conversion And Standards Job In Glaxosmithkline Pte Ltd In Bengaluru / Bangalore, India

Site Name: Bengaluru Luxor North Tower Posted Date: Apr 6 2023 Key Responsibilities Provide innovative solutions, lead, develop and deliver quality data conversion process as well as ensure operational delivery for portfolio Accountable and responsible for quality, cost, and consistency of SDTM & Programming delivery for in-house and outsourced studies across TA (Therapy Area) Responsible to implement, review and measure KPI (Key Performance Indicators) Identify data compliancy and data integrity issues ahead of time and raise the risk to senior management Identify/lead areas to improvement and implement automation to increase efficiencies.

Provide innovative solutions for the critical data flow Contributes to development of standards related documentation, eg, SOPs (Standard Operating Procedures), Guidance Documents, technical guidelines Define the training plan across various levels.

Lead the planning of multiple deliverables and priorities for the team Perform the RCA (Root Cause Analysis) and CAPA (Corrective Action and Preventative Action) for the problems and implement the solutions Knowledge on regulatory submissions including (JPMA/PMDA/FDA) and hands-on knowledge on programming data conversions Good amount of experience in providing timely technical solutions for the department in developing and delivering quality data conversion Provide proactive solutions based on the trend of the studies.

Acts as a Subject Matter Expert, mentors, and coaches' junior members of the team Be a primary point of contact for stakeholders (DM, DA, CP etc) wrt programming activities (SDTM / CQL / SAS Programming).

Ability to handle FSP (Functional Service Provider) teams and effectively communicate progress and challenges with deliverables to stakeholders Able to present in conferences and collaborate with other industry team members to understand industry trends Delegate tasks to other team members and oversee the quality and decisions made by team members Taking lead to develop new process / tools and guidelines for the team Articulate and explain technical concepts to the cross-functional CDM/DA/CP/Standards teams.

Responsible for conducting technical interviews for recruitment process Establish and maintain effective working relationships with partners and stakeholders Effective management of resources, by delegating responsibilities based on their strengths and potential Setting directions, Goal setting, performance evaluation and feedback .

Display stewardship in adhering to compliance expected activities and sets expectations within teams to ensure compliance parameters are met Minimum Level of Job-Related Experience Required Life-science or related medical/clinical area with around 13 plus years of experience and minimum 6 years of Line Management experience Extensive experience in delivering quality data conversion delivery within the organization Understanding different data conversion requirements across different TA and assets People leadership experience with direct/indirect reporting.

Experience with oncology and other TA portfolio delivery Experience co-ordinating and managing SDTMs review delivered by vendors for numerous studies CDISC - CDASH, SDTM and ADaM knowledge GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.

5 billion people around the world in the next 10 years Our success absolutely depends on our people While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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