408000 Clinical Trial Transparency Lead
408000 Clinical Trial Transparency Lead
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Job Description
Primary Responsibilities :
Drive endtoend process delivery and improvements in regulated and policydriven 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 patientlevel datasharing 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.
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.
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.
Role requirements :
The right candidate will possess a master s degree in Life Sciences and carry 610 years of core Clinical Trial Transparency experience with at least two years in a Lead or coordinating role.
Indepth 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.
Remote Work :
No
Employment Type
Full Time
