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Senior Manager, Clinical Trial Disclosure
2 months ago
CK Group is seeking a Senior Associate or Manager specializing in Global Clinical Trial Transparency and Disclosure for a prominent global pharmaceutical organization. This role is focused on ensuring adherence to disclosure protocols that align with the company's Clinical Trial Transparency policy and relevant regulations.
Key Responsibilities:
- Oversee and coordinate all tasks necessary to fulfill disclosure requirements for registration, maintenance, and results posting across various repositories, while guiding team members in disclosure operations.
- Collaborate closely with both internal and external teams to ensure a comprehensive understanding of transparency and disclosure obligations.
- Engage with vendors to guarantee that disclosure tasks are executed in accordance with established policies, procedures, and regulatory standards.
- Stay informed about current and emerging guidelines on disclosure processes, updating internal practices and conducting training as necessary.
- Support the implementation and enhancement of the disclosure system, participating as a Subject Matter Expert from initiation through deployment.
- Regularly assess disclosure activities for potential risks, ensuring that identified risks are monitored, managed, and that mitigation strategies are developed.
- Prepare and deliver training materials on the complete disclosure operations process, significant process changes, and related topics to all stakeholders involved.
- Promote awareness of clinical trial disclosure and its evolving requirements across the organization globally.
Candidate Profile:
To be considered for this role, candidates should possess:
- A degree or higher qualification in life sciences or a related discipline.
- A robust understanding of clinical disclosure regulations such as FDAAA801, EudraCT, and PhRMA/EFPIA principles for responsible data sharing.
- Demonstrated experience in clinical trial transparency or disclosure within the pharmaceutical sector, serving as a Subject Matter Expert in this field.
- A strong grasp of study registration and results disclosure processes.
- Insight into clinical development within the pharmaceutical industry.
- Exceptional communication and relationship-building skills, with the capability to manage projects with competing priorities in a matrix team environment.
