Senior Director of Data Management

3 weeks ago


Oxford, Oxfordshire, United Kingdom CTI Clinical Trial and Consulting Services Full time
Job Title: Senior Director, Data Management

We are seeking a highly experienced Senior Director to lead our Data Management function, ensuring the highest quality and compliance standards in our clinical and pharmacovigilance business.

Key Responsibilities:
  1. Develop and implement the global Quality strategy for Data Management, aligning with regulatory requirements and company standards.
  2. Collaborate with the Global Quality Leadership team to set long-term goals and priorities, driving business excellence and quality intent.
  3. Provide strategic guidance to senior leadership, influencing quality decisions and ensuring alignment with company objectives.
  4. Ensure preparedness for inspections, identify compliance vulnerabilities, and develop effective responses to inspectional observations.
  5. Verify data integrity principles are upheld in clinical development and pharmacovigilance activities, ensuring accuracy and reliability.
  6. Assess and report critical or major audit findings to the Vice President, Quality and Corporate Senior Management, driving corrective actions and improvements.
  7. Promote quality by design awareness among company personnel, developing and maintaining quality standards through training, review, advice, and guidance services.
  8. Manage and support activities for Company and Clinical Investigator inspections/external audits, acting as Inspection Lead/Host.
Requirements:
  • Substantial experience (typically 16+ years) in the pharmaceutical or biotechnology industry.
  • Substantial experience (typically a minimum of 7 years) in Quality leadership roles, including experience in GCP/GPvP cGLP.
  • Working knowledge of office IT packages, eQMS, and excellent written and verbal communication skills.
  • Minimum of a Bachelor's degree required in a science discipline or other relevant field. Post-graduate (Masters/PhD) preferred.


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