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.
Apply: https://jobs.gsk.com/en-gb/jobs/408000?lang=en-us&previousLocale=en-US