Job Description

Site Name: India - Maharashtra - Worli Mumbai Posted Date: Jun 16 2023 The role reports to the Head - Clinical Matrix Team and is an individual contributor role. Job Purpose To deliver the data management components of a series of clinical studies or project from data capture from multiple sources, through improving in-stream data flow, data cleanliness and data integration. Key Responsibilities Global study level contribution as Study Data Manager (SDM) or in close collaboration with SDM and other members of the study team. Point of contact for more complex data management and data quality considerations including regular contact with monitors. Provides input to protocol and other plans e.g. Monitoring Plan, Protocol Deviation Management Plan, and Reporting & Analysis Plan during the planning phase. Manages in-stream data flow activities and delivers a quality database in accordance with the Data Management Plan. Inputs into the data capture tools for a clinical study, including the eCRF and eCOA. Develops and manages the Data Management Plan, execution of the validation and integration plans, including dataset definitions and external data sources. Manages vendor performance against study-specific Service Level Agreements. Responsible for the set-up and maintenance of TMF section 10 and DM TMF artefacts throughout the study life cycle. Subject Matter Expert for the Data Management Community in a specified area(s) of functional expertise. Accountable for the development of the Study Data Quality Plan to ensure data is fit for purpose of the study. Lead database release and freeze activities, ensuring released data fulfilled quality level defined in Study Data Quality Plan Builds relationship with external organization such as CROs, AROs and other business partners to ensure integrity of data captured by other organizations. Engage EST, CRF/eCRF designer/programmer, Statisticians, Monitors, site staff and other stakeholders with necessary expertise, in development of data capturing tool(s) Candidate Requirements Qualification : Bachelor\'s Degree or equivalent Experience : Minimum of 5 years experiences Clinical Data Manager Experience as Project manager is preferred. Understanding of applicable ICH/GCP regulations and applicable GSK policies and SOPs Experience working with key global preferred suppliers/ partnerships to ensure deliverables are to the agreed standard. Deep and broad knowledge and skills on Clinical Data Management and data standards Good knowledge and skills on computer programming and systems Good communication skills Demonstrates the discipline of risk-based planning Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets. 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 positively impact the health of 2.5 billion people by the end of 2030. 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. 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