Senior Clinical Data Scientist

Site Name: China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18 Posted Date: Dec 4 2022 Role Purpose 职位目标： Senior Study Data Management Quality Leader with the responsibility of oversight all DM deliverables for one or several complex studies by DM Functional Service Provider (FSP) or Full Service Outsourced (FSO) to the agreed quality, timelines and budget. Work closely with his/her manager to implement innovation focused on technology solutions for Data Management in China Development organization. He/her will connect with global Data Strategy and Management (DS&M), China Tech group and business functions in China Development to build innovative tools/technologies to enable acceleration and contribute innovative ideas. This role will also support the China central lab data process, flow, and quality. Key Accountabilities/Responsibilities 主要工作职责： Study level contribution as Study Data Manager or Data Management Quality Lead（DMQL） in close collaboration with DMQL the DM asset lead. Point of contact for data management and data quality strategies at the study level Accountable for study Data Management Plan 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 study Data Management Plan. Inputs into the data capture tools for a clinical study, including the eCRF and eCOA. Lead data review within study team by using appropriate technology and visualization tools. IPE and EPE budget forecasting and on-going budget management of data management operational contract staff and third-party vendors for the assigned level (project or study) under the supervision of the principal CDS or the data management director Develops and manages the execution of the validation and integration plans, including dataset definitions, for 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. Trains monitors and site staff on use of data collection tools and query management process. Work with DM and Tech team to optimize or develop innovative tools for the whole lifecycle of clinical trial, to enable acceleration and contribute innovative ideas Inputs to central monitoring on data quality across all China studies Work with manager to setup the quality control and standardization framework for external data, including central labs Why you? Basic Qualifications: Educated to at least Bachelor level in Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent. Master’s degree preferred. Minimum 8 years in similar or related job experience at a multinational pharmaceutical company or Clinical Research Organization (CRO) in Clinical Research or Information Systems and/or relevant scientific experience Experienced in Data Management and Clinical Systems including external vendor data solutions in the pharmaceutical industry Familiar with Microsoft Excel, SAS, and programming software Hands on CDISC conversion experiences Competencies: Strong innovative mindset and drive for execution. Leads deliverables for multiple China pivotal studies at any point in time. Oversight study level data quality including vendor Oversight Develops and implements new data types and therapy area standards. Develops recommendations for study or project issue resolution. The ability to build relationships and convey ideas, information, and instructions clearly and compellingly Negotiates with third party vendors on the data quality requirements and DM budgets. Ability to develop the tools to identify the data trends and risks and implement risk-based data monitoring. Understanding of general data flow & database architecture concepts Understanding of eCRF design systems, standards, and processes Knowledge of clinical trial design elements and potential issues Understands data sources for CRF design purposes Good understanding of ICH-GCP and regulatory requirements as they relate to data collection systems and activities Knowledge of clinical and pharmaceutical drug development process Knowledge of data privacy Strong Knowledge of industry CDISC standards Knowledge of Industry SOPs and regulatory requirements relating to data quality Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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