Job Description

Site Name: Bengaluru Luxor North Tower Posted Date: Nov 10 2023 The Manager, Document Anonymisation provides a critical role in the preparation of anonymised clinical documents to meet GSK\'s clinical document disclosure obligations. These include regulatory (e.g. EMA Policies 0070 and 0043, Health Canada, NIH, EUCTR), external data sharing and policy requirements. The Manager, Document Anonymisation is required to prepare clinical documents for anonymisation and to ensure that all personal and company confidential information is anonymised or removed in adherence with GSK written standards prior to disclosure. The role is required to provide support to all therapy areas in GSK R&D who prepare anonymised documents. The job-holder is required to interact with a diverse group of global functions, including other groups within Medical Governance and Data Disclosure, study teams in clinical, Epi and Value Evidence Outcomes, document anonymisation vendor(s), off-shore service providers, publishing and regulatory teams. Key Responsibilities : Manage the daily operations of anonymizing clinical documents. Establish priorities for anonymization and data verification and ensure the proper controls are in place and review the outputs of anonymization to ensure quality of information for external researchers. Have overall accountability of the document anonymization capability, driving development, competence, overall strategy both internally and externally. Maintain a strong relationship with internal business partners and act as a key contact supporting SHARE and Statistics and Programming, Medical and Regulatory Policy, Therapeutic areas and other relevant functions for both current and historical studies. Create a community of practice to establish greater cross communication between central, medical policy and statistics and programming groups. Contribute to industry and regulatory standards for data re-use and anonymization. Be part of the governance model for the processes/systems that impact delivery of Transparency commitments. Work closely with the Director Clinical Data Transparency and Director of Data Sharing align GSK processes to impending disclosure regulations. Act as a subject matter expert on the regulatory requirements for document anonymization, including EMA Policy 070 and Health Canada Manage business relationships with external vendors to ensure simple and efficient models for anonymizing clinical documents, and for delivering quality, on time and in line with GSK expectations. Serve as the Business Capability Lead/Subject Matter Expert for the document anonymization capabilities, including system/technology, regulatory inspection/internal audit. Proactively devise process improvements based on feedback from clinical groups and governance bodies to ensure GSK meet our commitments. Proactively meet with teams authoring clinical documents and propose working practices to minimize the PI and CCI contained within clinical documents Ensure proper documentation and oversight of all business processes, standard procedures and work instructions related to document anonymization capability ensuring compliance with regulatory requirements Monitor new technologies and external trends to ensure GSK is leveraging the best of what is available. Minimum Level of Job-Related Experience Required: At least 6 years of experience in scientific writing, regulatory writing, publications writing or equivalent. Experience in Pharmaceutical company environment and specifically in matrix organization Experience in managing clinical trial (study, data, or system/technology) activities. Good understanding of clinical trial lifecycle, clinical trial metadata [i.e. information about the trials], clinical trial data [i.e. observed data collected as part of the trial], clinical documents. Why Us 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 organization 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. 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. 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