This role is primarily accountable for implementation of elements of the strategic plan to meet GSK’s commitments and to focus the Pharma R&D organisation on consistent, readily accessible, inspection ready and available clinical documentation in the shape of a TMF for every study.
Areas of focus for this job include: TMF management, records retention, archiving, International Conference on Harmonisation/Good Clinical Practice regulations for managing sponsor study records, industry standards for clinical information management, application of data privacy legislation for data use and reuse.
• Support the embedding and implementation of eTMF and associated systems across Pharma R&D by working directly with Study Teams and other stakeholders as they use the eTMF system to ensure inspection readiness throughout the study lifecycle.
• Work with the business to improve our understanding of the challenges and associated solutions to ensure excellence in inspection readiness on a day-to-day basis.
• Involvement in the development of high-quality end to end process guidelines, best practices and standards focusing on effective and efficient clinical documentation management in collaboration with the other business partners.
• Analyse business problems/opportunities, develop and deliver high quality solutions that will impact customer groups.
•Support business management monitoring activities for the business process owner, harness metrics data in support of decision making and action plans, analyse trends to get insights on pain points, technical and training needs.
•Participate in change management and/or process improvement initiatives and/or IT projects analysing business problems/opportunities, develop and deliver high quality solutions that will impact customer groups.
Basic Qualifications• Knowledge and experience with the use of TMF systems and associated business processes, ideally including Veeva applications.
• Excellent working knowledge of International Conference on Harmonisation/Good Clinical Practice regulations and Drug Information Association (DIA) Trial Master File (TMF) Reference Model.
• Able to build a project plan & business case (including costing, metrics and timelines), with guidance, to deliver a technical/business solution.
• Proven ability to provide effective consultation, training and analyse business problems/opportunities.
• Superior interpersonal skills, including the ability to establish and maintain good working relationships with peers, colleagues and management.
• Excellent written and oral communication.
• Ability to work independently and make decisions with minimal supervision.
• Proven record of continuous improvement, especially with regard to emerging clinical information management practices.
• Excellent influencing skills.
All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!
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