Principal Data Acquisition Specialist - EDC Development

Bayer Inc. ,
Reading, Berkshire
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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change Principal Data Acquisition Specialist - EDC Development Major tasks and responsibilities include: Organize and lead the development team within and outside of DS&A (includes Study Manager, Study Medical Expert, Study Statistician, Study Lead Monitor and Study Data Manager) Develop expertise in compound requirements to ensure that all data collection requirements are identified from protocol and accounted for in the setup phase to receive data within specific compounds Understand and ensure connectivity with collected clinical trial data from beginning to end (i.e., investigator, and patient data entry to internal data review, cleaning, and analysis by study team members) Analyze the medical data standards and define implementation of the same for operational use within studies with appropriate details such as technical annotations, associated eCRF setup, required quality checks etc Develop study level specifications for data elements across platforms and ensure that they are complete and comprehensive and include programming of any study level integrations Setup study/library level data elements using available software including programming of edits, and derivations as required Complete in a timely manner all documentation for study setup in compliance with the applicable SOP and support audits and/or inspections of the same Perform impact analysis for changes to medical data standards that are in use in studies and present implementation strategy for study teams Create and monitor the study/library setup timelines in accordance with development SOPs and OMs Collaborate closely within and outside of DS&A (i.e., GCL/GCPM, Project Data Manager, Project Statistician, Medical Standards Manager) to implement compound specific requirements within studies ensuring availability of clinical trial data soon after collection at investigator sites Ensure setup and availability of reports and tools to facilitate data management actions Support compound requirements training for users to ensure adherence to standards and implementation as established by compounds and CS teams Promote knowledge sharing within and outside of DAI to ensure cross- platform data connectivity within studies and libraries Maintain assigned study/library elements including making updates to elements that are in production use ensuring that all updates are fully tested before deployment Perform other duties as assigned Qualifications, Experience and Skills Masters with 6years of experience Bachelors with 8 years of experience Bachelor's/Master's degree in a natural science, Statistics, Computer Science or a related field Experience in definition and setup of data acquisition elements in the clinical trials across different TAs and Phases of drug development is required Experience and knowledge of the clinical trial data management and/or data analysis process is required Experience in leading global clinical team with effective management of activities to deliver quality study level setup is required Effective time management and ability to independently manage study setup and maintenance activities is required Understanding the usage of medical data standards (i.e. sponsor specific or CDISC) in context of study is required EDC Study build experience (Preferably Rave) Your Application: At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change. Reward is important to us, employees benefit from excellent employment conditions, such as: * competitive salary and performance bonus * 25 days annual leave plus bank holidays * Private Healthcare, generous pension scheme and Life Insurance * Employee discount scheme * State of the art offices (award winner for British Council for Offices, Best Fit Out Category 2018) * International career possibilities * Flexible working Are you up for the challenge? If so, please apply below. #LI-UK Location: United Kingdom : Berkshire : Reading Division: Pharmaceuticals Reference Code: 172284

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