Senior Associate Manager Disclosure Global Clinical Trial Transparency
2 days ago
CK Group is seeking a highly skilled Senior Associate or Manager to join our team as a Global Clinical Trial Transparency and Disclosure Specialist. This is a fixed-term contract position for 12 months, based in Hatfield, Hertfordshire.
Key Responsibilities- Disclosure Compliance: Ensure compliance with disclosure processes that support the company's Policy for Clinical Trial Transparency and applicable regulations.
- Team Support: Collaborate with internal and external team members to ensure Global Clinical Trial Transparency disclosure responsibilities are achieved.
- Vendor Management: Work closely with vendors to ensure disclosure obligations are performed in compliance with policy, procedures, and applicable regulations.
- Process Improvement: Maintain awareness of existing and emerging guidance on disclosure processes, updating internal processes and performing training where needed.
- System Implementation: Support and contribute to the implementation and upgrade of the disclosure system, from initiation to deployment.
- Risk Assessment: Contribute to the regular assessment of disclosure activities for risk, and track, manage, and develop mitigation and implementation strategies.
- Training and Awareness: Prepare training materials and deliver training on end-to-end disclosure operations process, important process changes, and other associated topics to stakeholders.
- Education: Educated to degree level or above in life sciences or a related field.
- Knowledge: Strong working knowledge of clinical disclosure rules such as FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing, etc.
- Experience: Proven and demonstrated experience with clinical trial transparency or disclosure within the pharmaceutical industry as an SME within the clinical trial disclosure area.
- Skills: Excellent communication and relationship building skills with the ability to drive projects with conflicting priorities in a matrix team environment.
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Hatfield, Hertfordshire, United Kingdom CK Group Full timeJob DescriptionCK Group is seeking a highly skilled Senior Associate Manager to join our team in Hatfield, Hertfordshire. As a Senior Associate Manager, Global Clinical Trial Transparency and Disclosure, you will play a critical role in ensuring compliance with disclosure processes and supporting the activities of team members assigned to disclosure...
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Hatfield, Hertfordshire, United Kingdom CK Group Full timeJob DescriptionCK Group is seeking a highly skilled Senior Associate Manager to join our team in Hatfield, Hertfordshire. As a Senior Associate Manager, Global Clinical Trial Transparency and Disclosure, you will play a critical role in ensuring compliance with disclosure processes and supporting the activities of team members assigned to disclosure...
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Hatfield, Hertfordshire, United Kingdom CK Group Full timeJob DescriptionCK Group is seeking a highly skilled Senior Associate Manager to join our team in Hatfield, Hertfordshire. As a Senior Associate Manager, Global Clinical Trial Transparency and Disclosure, you will play a critical role in ensuring compliance with disclosure processes and supporting the activities of team members assigned to disclosure...
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Hatfield, Hertfordshire, United Kingdom CK Group Full timeJob DescriptionCK Group is seeking a highly skilled Senior Associate Manager to join our team in Hatfield, Hertfordshire. As a Senior Associate Manager, Global Clinical Trial Transparency and Disclosure, you will play a critical role in ensuring compliance with disclosure processes and supporting the activities of team members assigned to disclosure...
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