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Senior Associate Manager

2 months ago


Hatfield, Hertfordshire, United Kingdom CK Group Full time
Job Description

CK Group is seeking a highly skilled professional to fill the role of Senior Associate Manager, Global Clinical Trial Transparency and Disclosure. 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 Collaboration: Work closely with internal and external teams to fulfill and ensure that they understand transparency and disclosure obligations.
  • Vendor Management: Collaborate with vendors 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 as 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 as needed.
  • Training and Awareness: Prepare training materials and deliver training on end-to-end disclosure operations processes, important process changes, and other associated topics to all stakeholders involved.
Requirements:
  • 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 on clinicaltrials.gov, understanding of clinical development within the pharmaceutical industry, and excellent communication and relationship building skills.