Senior Associate Manager, Global Clinical Trial Transparency and Disclosure
5 days ago
CK 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 operations.
Key Responsibilities:- Disclosure Obligations: Perform and coordinate all activities to meet disclosure obligations for registration, maintenance, and results posting on relevant repositories, ensuring team members follow process.
- Transparency and Disclosure: Work closely with internal and external teams to fulfill and ensure that they understand transparency and disclosure obligations.
- Vendor Management: Work closely with the vendor to ensure that 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 that any risks identified are tracked, managed, and potential mitigation and implementation strategies are developed.
- Training and Awareness: Prepare training materials and deliver training on end-to-end disclosure operations process, important process changes, and other associated topics to all stakeholders involved.
- Global Awareness: Contribute to raising awareness of clinical trial disclosure and its changing requirements within the company globally, as required.
- Education: Educated to degree level or above in life sciences or a related field.
- Knowledge: Strong working knowledge of clinical disclosure rules such as FDAAA 801, 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: Strong working knowledge of study registration and results disclosure, understanding of clinical development within the pharmaceutical industry, 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 SummaryCK 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 ResponsibilitiesDisclosure Compliance: Ensure compliance with disclosure processes that support the company's...
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Hatfield, Hertfordshire, United Kingdom CK Group Full timeJob SummaryCK 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 ResponsibilitiesDisclosure Compliance: Ensure compliance with disclosure processes that support the company's...
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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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