Manager, Data Management

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About the role

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary The Manager, Clinical Data Management is responsible for overseeing the end to end Data Strategy & Management (DS&M) study related activities and is accountable for all Data Management study deliverables in terms of quality & delivery to plan. This role mentors other DS&M team member(s) and acts as Subject Matter Expert. Responsibilities • Accountable for the end to end DS&M study related activities in terms of quality & delivery to plan which include: o Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments o Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation o Interim and final cleaned database lock o Archival of all DM documents in the eTMF o Archival of the study database and provision of clinical data to the study site • Accountable for one or several complex studies, and has the ability and experience to manage the delivery of any type of study (different therapeutic areas, complex/unusual early phase setting, new/unusual indication, pivotal/Phase III and efficacy studies, clinical as well as epidemiology studies) • For an in-house study, leads the day to day DS&M operational study related activities, acts as a member of the study core team and is the single point of contact for all the DM study related activities & matters • For a study 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 and ensures training on the protocol to the FSP resources working on the study • Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register • Provides reports, status updates, feedback and advice to key study stakeholders on study progress. • May oversees and provides input to the development of budgets forecasts for FSP and FSO contracts. • Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these • Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity • Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level • Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines • Develops and maintains excellent professional relationships with study team and other key stakeholders • Acts as a mentor for junior members of the DS&M team • Acts as a Subject Matter Expert supporting the implementation of new processes, data standards, trainings, systems, vendor quality assessments, audits and inspections Basic Qualification • Bachelor’s Degree, in scientific or business discipline • The individual in this role needs to be able to manage varied and multiple studies associated with the size and complexity of the clinical trial phases and Therapeutic areas. This requires a skilled, d

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