Associate Director, Data Management

Site Name: Bengaluru Luxor North Tower Posted Date: Nov 14 2022 Ready to help shape the future of healthcare? 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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Job Purpose: - The Associate Director, Data Management is responsible for overseeing the end-to-end data management delivery for an asset and/or group of studies and is accountable for all DS&M study deliverables in terms of quality & delivery to plan. The role manages stakeholders at the asset level, escalates risk appropriately and sets expectations with suppliers. This role mentor's other data managers, acts as a Subject Matter Expert and may include line management. Key Responsibilities: - • Accountable for several studies in a clinical development program and has the ability and the seniority to manage the delivery of any study type, in-house, outsourced through a DM Functional Service Provider (FSP) or Full Services Outsourcing (FSO). • Conducts & documents sponsor oversight of the end-to-end FSP/FSO study related activities. • Represents DM at the Asset level, providing status updates, feedback, and advice to key stakeholders on progress. • Provides DM input into the study design, the protocol, study planning, study documents including the study risk register and monitoring plan in line with value driven data cleaning principles. • Develops and maintains excellent professional relations with the asset and/or study teams and other key stakeholders. • Acts as the first point of escalation for all asset level DM issues and risks. Understands, mediates, and solves issues related to DM deliverables and escalates as required to DM representative on DS&M LT. • Manages vendor performance and ensures DM deliverables are following GSK SOPs (Standard Operating Procedure) and regulatory guidelines. • Oversees and provides input to the development of budgets and resource forecasts for FSP and FSO contracts. • Acts as a Subject Matter Expert, mentors, and coaches more junior members of the team. • Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity. • Leads the implementation of new processes, provide input on associated written standards & trainings, vendor quality assessments, audits, and inspections. • Engages externally to keep abreast of industry trends in data management. • May recruit and develop Data Management staff including objective setting, development feedback, coaching and conduct regular performance reviews. Knowledge/Education Required:- Minimum Level of Education Required - Bachelor’s Degree, in scientific or business discipline Preferred Level of Education - Post Graduate Degree in Scientific Discipline Area of Specialization - Clinical trial experience. Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP). Understanding of the tools of the trade, such as standards. Previous Experience Required: - • Pharma, CRO and/or Academic Research Organisation experience. • Understanding of disease area. • Understanding of laboratory data. • Understanding of applicable ICH/GCP regulations and applicable GSK policies and SOPs Job-Related Experience sections above that are required for the job: - • Experience working with key global preferred suppliers/ partnerships to ensure deliverables are to the agreed standard • Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets • Operates across a global, complex organization. Includes applying the processes, methods, tools and approaches used to manage data management activities, and the day-to-day running of a study or project-aligned team • Develops and implements new data collection strategies and therapy area standards • Develops recommendations for study (or project) issue resolution • Builds influential networks within the organization. Uses these relationships to generate buy-in and support for the project, Data Management Plan or equivalent, to ensure mutually advantageous resources and goals • Influences key study or project team members or roles to meet the overall goal • Gains buy-in from the Clinical Sciences Lead (CSL), Study Delivery Lead (SDL), Statistician, Clinical Programmer (CP) and other study team colleagues for data management agreements • Works within a global network within the GSK Data Management community to ensure knowledge sharing and learning from the collective experience • Communicates technical topics to a non-technical audience. • Uses a network within GSK and external to keep abreast of industry trends and apply on studies in scope. Certification: CCDM (if present) added advantage At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. *LI-GSK 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. 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