Associate Transparency Specialist - Document Anonymisation GSK

4.0 - 8.0 years

0 Lacs

karnataka

On-site

As a Clinical Document Anonymization Specialist at GSK, your primary responsibility will involve preparing and anonymizing clinical documents in adherence to GSK's established standards. You will be tasked with ensuring meticulous documentation and oversight of all processes, procedures, and work instructions related to document anonymization to ensure compliance with regulatory requirements. Additionally, you will oversee and coordinate with external vendors and offshore service providers supporting the document anonymization and data sharing process. Your role will also involve monitoring the quality of information received from document anonymization partners through quality control and assurance efforts. You will play a crucial role in maintaining strong relationships with both external and internal business partners, effectively communicating to resolve issues hindering the disclosure of clinical documents and ensuring timely delivery as per agreed timelines and priorities. Your contribution will be essential in developing procedural and training documentation for document anonymization, as well as efforts to ensure the quality and consistency of anonymization standards and storage of clinical documents within the R&D framework. To be successful in this role, you should have a minimum of 4 years of experience in document anonymization, regulatory requirements, and stakeholder management. A Master's degree in life sciences is required, along with a solid understanding and prior experience in anonymization of clinical documents for EMA Policy 0070 and Health Canada PRCI. Experience in managing clinical trial activities, a good grasp of clinical trial lifecycle, metadata, and data, as well as excellent communication skills, attention to detail, and the ability to work independently are essential qualifications. Additionally, possessing a good understanding of R&D and clinical development processes, the ability to bridge communication gaps between scientific and non-scientific organizations, and manage conflicting demands in a high-pressure environment will be advantageous. Awareness of medical writing, publishing, and regulatory processes will also be beneficial to excel in this role. Join GSK, a global biopharma company dedicated to uniting science, technology, and talent to combat diseases and positively impact the health of billions worldwide. At GSK, we foster an environment where individuals can thrive, grow, and contribute to our mission of getting ahead of disease together. If you are motivated by our ambition and seek a place where you can be inspired, valued, and challenged to be your best, join us on this exciting journey to make a difference in healthcare. Please be advised that GSK does not accept referrals from employment businesses or agencies without prior written authorization. If you encounter unsolicited emails or job advertisements not from gsk.com, kindly disregard them and reach out to us at askus@gsk.com for verification of job authenticity.,

Posted 6 days ago

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