Overview :The Clinical Trial Transparency (CTT) Lead is responsible for leading the delivery of end-to-end data transparency/disclosure of worldwide GSK Human Subject Research (HSR).Key responsibilities include directing the core delivery team to ensure consistent, timely and complete delivery of key clinical trial documents/information, as required by disclosure regulations and policy, for submission to key external registers (e.g. ClinicalTrials.gov, EU Clinical Trial Register and the GSK Study Register). The CTT Lead plays a key role to establish, roll-out and promote consistent process for disclosure activities for HSR throughout the global organization and ensure oversight for maintenance and improvement of processes for public disclosure function according to evolving requirements. The role will report into the Operations Head, Clinical Trial Transparency.Primary Responsibilities :·Drive end-to-end process delivery and improvements in regulated and policy-driven clinical disclosures and data sharing.·Serve as the primary point of contact for project teams and functional matrix teams for Clinical Trial Transparency activities.·Assess HSR trials for disclosure and patient-level data-sharing requirements and guide study teams through the achievement of complete, consistent, and timely disclosure and listing of studies in scope of public disclosure registries.·Collaborate with a team of recognized subject matter experts to ensure quality of output.·Work with outsourced resources (platforms, consultants) as required, to ensure transparency delivery in compliance to GSK Policy and SOPs.·Oversee workload distribution and establish/ maintain a robust communication interface across all people involved in the delivery of the documents. Act as primary point of contact for service provider(s).·Monitor quality of output delivered by individual members of the team.·Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translate into GSK’s Clinical Trial Transparency strategy.·Proactively identify business transparency risks and propose and implement strategies to manage the implications of these risks on the business. Support risk management framework implementation, including risk identification, assessment and prioritisation and the development of mitigation plans.·Develop and maintain knowledge and expertise in the Transparency environment. Partner with key internal stakeholders to strengthen and ensure that GSK practices for Policy requirements are in line with relevant internal and external requirements.Role requirements :The right candidate will possess a master’s degree in Life Sciences and carry 6-10 years of core Clinical Trial Transparency experience, with at least two years in a Lead or coordinating role.In-depth and applied knowledge of Transparency regulations (eg: FDAAA Final rule and EU CTR) is fundamental to succeed in the role. Strong communication and stakeholder management skills, especially with global matrix teams, is essential. Demonstrated ability to influence without authority is key.Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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