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Hatfield, Hertfordshire, United Kingdom CK Group Full timeJob Title: Senior Associate Manager Global Clinical Trial TransparencyCK Group is seeking a highly skilled Senior Associate Manager to join our team in Hatfield, Hertfordshire. As a Senior Associate Manager, you will play a key role in ensuring compliance with clinical trial transparency and disclosure processes.Key Responsibilities:Ensure compliance with...
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Clinical Trial Transparency Specialist
2 months ago
About Eisai
Eisai is a leading research-based pharmaceutical organization with a comprehensive portfolio across Oncology, Neurology, and Pain therapy areas. Driven by a human healthcare philosophy, Eisai prioritizes patient well-being in all its endeavors.
Your Role: Clinical Trial Transparency Specialist
As a Clinical Trial Transparency Specialist, you will play a vital role in ensuring Eisai's compliance with global clinical trial transparency regulations. You will contribute to the execution of disclosure operations, collaborating with internal and external teams to achieve Eisai's commitment to transparent clinical trial data sharing.
Responsibilities:
- Support Eisai's Global Clinical Trial Transparency (GCTT) initiatives by assisting in the preparation and submission of clinical trial disclosures.
- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and medical writing, to ensure accurate and timely disclosure submissions.
- Maintain a thorough understanding of relevant regulations and guidelines, such as FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing, etc.
- Contribute to the development and implementation of processes and tools to streamline GCTT operations.
- Stay abreast of industry best practices and emerging trends in clinical trial transparency.
Qualifications:
The ideal candidate will possess a strong understanding of clinical trial regulations and a commitment to data transparency.