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Clinical Trials Operations Manager (Regulatory) provides senior-level operational oversight across regulatory affairs, quality assurance, monitoring, and pharmacovigilance activities within a major academic cancer trials centre.
Job Responsibility:
Strategic and operational support to senior leadership
Oversee quality assurance, monitoring, pharmacovigilance, and data science teams
Ensure adherence to protocols, GCP, SOPs, and regulations
Develop and refine operational systems and SOPs
Lead staff management, evaluations, training, and recruitment
Contribute to Senior Management Group
Support funding reports and reviews
Liaise with MHRA and HRA
Lead preparation for regulatory inspections
Represent the centre nationally and internationally
Promote organisational values and sustainability
Perform duties within scope of the role
Requirements:
Degree or equivalent experience
Substantial experience within a trial sponsor environment
Knowledge of UK/EU trial regulations and pharmacovigilance