Job Title: Clinical Trial Transparency (CTT) Lead
Site Name: Bengaluru Luxor North Tower
The Clinical Trial Transparency (CTT) Lead is responsible for leading the delivery of end-to-end data transparency and disclosure of worldwide GSK Human Subject Research (HSR). The role involves directing the core delivery team to ensure the consistent, timely, and complete delivery of key clinical trial documents/information as required by disclosure regulations and policy. This includes submission to key external registers, such as ClinicalTrials.gov, EU Clinical Trial Register, and the GSK Study Register. The CTT Lead plays a key role in establishing, rolling out, and promoting consistent processes for disclosure activities throughout the global organization and ensuring oversight for the maintenance and improvement of these processes according to evolving requirements. The position will report into the Operations Head, Clinical Trial Transparency.
End-to-End Process Delivery: Lead and drive the end-to-end process for clinical disclosures and data sharing in compliance with regulations and policy-driven requirements.
Primary Point of Contact: Serve as the main contact for project teams and functional matrix teams concerning clinical trial transparency activities.
Assessment of HSR Trials: Assess HSR trials for disclosure and patient-level data-sharing requirements, guiding study teams to ensure complete, consistent, and timely disclosure and listing in public disclosure registries.
Collaboration with SMEs: Work with a team of recognized subject matter experts to ensure the quality of the output.
Outsourced Resource Management: Collaborate with outsourced resources (e.g., platforms, consultants) to ensure transparency delivery in compliance with GSK policies and SOPs.
Workload Distribution: Oversee workload distribution, ensuring robust communication across all individuals involved in delivering the required documents, and act as the primary point of contact for service providers.
Quality Monitoring: Monitor the quality of output delivered by individual team members.
Regulatory Awareness: Stay updated on changes in the disclosure, transparency, and data-sharing landscape, including new legal, regulatory requirements, and industry trends. Translate these into GSK’s clinical trial transparency strategy.
Risk Management: Identify business transparency risks proactively and propose strategies to manage their implications. Support the implementation of the risk management framework, including risk identification, assessment, prioritization, and development of mitigation plans.
Partnership with Stakeholders: Develop and maintain knowledge of the transparency environment. Partner with internal stakeholders to ensure GSK’s practices meet both internal and external policy requirements.
Education: Master’s degree in Life Sciences.
Experience: 6-10 years of core clinical trial transparency experience, with at least 2 years in a lead or coordinating role.
Knowledge: In-depth knowledge and applied experience of transparency regulations (e.g., FDAAA Final Rule, EU CTR).
Skills:
This role requires someone with extensive experience in clinical trial transparency, the ability to navigate complex regulatory environments, and the capacity to lead cross-functional teams effectively.
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