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Senior Associate Clinical Director

2 months ago


Hatfield, Hertfordshire, United Kingdom CK Group Full time

CK Group is seeking a highly skilled professional to fill the role of Senior Associate Clinical Director, Global Clinical Trial Transparency and Disclosure. This is a fixed-term contract position for 12 months, based in Hatfield, Hertfordshire.

Key Responsibilities:
  • Ensure compliance with disclosure processes and regulations, supporting the company's policy for Clinical Trial Transparency.
  • Work closely with vendors to ensure disclosure obligations are met in accordance with policy, procedures, and applicable regulations.
  • Maintain awareness of existing and emerging guidance on disclosure processes, updating internal processes and providing training as needed.
  • Support the implementation and upgrade of the disclosure system, from initiation to deployment.
  • Contribute to the regular assessment of disclosure activities for risk, tracking and managing identified risks, and developing mitigation strategies.
  • Prepare and deliver training on end-to-end disclosure operations, process changes, and other associated topics to stakeholders.
  • Raise awareness of clinical trial disclosure and its changing requirements within the company globally.
Requirements:
  • Educated to degree level or above in life sciences or a related field.
  • Strong working knowledge of clinical disclosure rules, including FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing.
  • Proven experience with clinical trial transparency or disclosure within the pharmaceutical industry, with expertise in the clinical trial disclosure area.
  • Understanding of clinical development within the pharmaceutical industry.
  • Excellent communication and relationship building skills, with the ability to drive projects in a matrix team environment.