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Senior Manager, Clinical Trial Disclosure
2 months ago
CK Group is seeking a Senior Associate or Manager for Global Clinical Trial Transparency and Disclosure within a prominent global pharmaceutical organization. This role is offered on a fixed-term contract basis.
Key Responsibilities:
- Ensure adherence to disclosure protocols that align with the company’s Clinical Trial Transparency policy and relevant regulations.
- Coordinate and oversee all tasks necessary to fulfill disclosure requirements for registration, maintenance, and results posting on applicable platforms.
- Collaborate with both internal and external teams to clarify transparency and disclosure responsibilities.
- Engage with vendors to guarantee compliance with policies, procedures, and regulatory standards regarding disclosure obligations.
- Stay informed about current and emerging guidelines related to disclosure processes, revising internal protocols and providing training as necessary.
- Act as a Subject Matter Expert (SME) in the implementation and enhancement of the disclosure system, from initiation through to deployment.
- Regularly evaluate disclosure activities for potential risks, ensuring that identified risks are documented, managed, and that mitigation strategies are established.
- Develop and present training materials on the comprehensive disclosure operations process and significant process updates to all relevant stakeholders.
- Promote awareness of clinical trial disclosure and its evolving requirements across the organization.
Candidate Profile:
To be considered for this role, candidates should possess:
- A degree in life sciences or a related discipline.
- In-depth knowledge of clinical disclosure regulations such as FDAAA801, EudraCT, and principles for responsible data sharing.
- Demonstrated expertise in clinical trial transparency or disclosure within the pharmaceutical sector.
- Strong familiarity with study registration and results disclosure processes.
- An understanding of the clinical development landscape in the pharmaceutical industry.
- Exceptional communication and relationship management skills, with the capability to lead projects amidst competing priorities in a matrix environment.
