Ronim S.

Manager, Clinical Data Transparency @Johnson & Johnson Innovative Medicine

High Wycombe, GB

Acts as a top-level specialist to establish programs and new initiatives for the organisation to advance Clinical Data Transparency priorities.• Is part of the Management team within the Clinical Registry group, who’s main areas of responsibility, amongst others, include ClinicalTrials.Gov Protocol Registration process, International/Country-specific registries and the HMA-EMA Catalogues. Supports team members with Study Escalations and complex study discussions with the Study Teams and Stakeholders, to achieve a satisfactory resolution, which ensures both quality and compliance.• Responsible for Vendor Oversight for one of the Disclosure Vendors, to ensure that they are delivering and performing according to internal requirements and also chairs the Governance meetings with them.• Acts as a Subject Matter Expert and Individual Contributor in Clinical Data Transparency, working independently with minimal supervision.• Manages projects, programs and processes that span multiple related areas in support of the organisation’s overall Clinical Data Transparency strategy.• Understands, communicates and applies in-depth knowledge of Clinical Data Transparency to maintain, improve and ensure adherence to Clinical Data Transparency policies, procedures and plans for clinical registries, document anonymisation and sharing, plain language summaries or data anonymisation and sharing.• Helps implement Clinical Data Transparency capabilities and roadmap, including strategic priorities for Clinical Data Transparency.• Reviews critical quality issues to drive root cause assessment and mitigation planning.• Understands regulatory and industry trends in Clinical Data Transparency and anonymisation to integrate trends and best practices.• Coaches and trains junior colleagues in techniques, processes and responsibilities.• Supports continuous process and technology improvements.• Integrates J&J Credo and Leadership Imperatives into team goals and decision-making.

King's College London, U. of London

MRes

King's College London, U. of London

AKC Associateship of King's College

King's College London, U. of London

BSc (Hons)