Clinical Operations Director EU

2 weeks ago


Oxford, Oxfordshire, United Kingdom Amber Therapeutics Full time

Clinical Operations Manager EU

Amber Therapeutics is seeking an experienced Clinical Operations Manager to lead the EU clinical operations team. This role will ensure clinical trials are managed to objectives, timelines, budget, and quality expectations.

  • Promote and implement best practices in EU clinical operations to support the development of innovative medical devices.
  • Develop and maintain strong relationships with key stakeholders, including Principal Investigators, CROs, and external partners.
  • Conduct site initiation visits, interim and closure visits, and ensure compliance with regulatory requirements.
  • Manage the clinical trial budget, ensuring timely and cost-effective delivery of trials.
  • Compile and submit regulatory documents, including Clinical Evaluation Plans and Reports.
  • Develop and maintain departmental procedures in line with regulatory requirements.
  • Collaborate with cross-functional teams to ensure seamless delivery of clinical trials.
  • Maintain accurate and complete records of clinical trial data and ensure compliance with data protection regulations.

Requirements

  • Bachelor's degree in a scientific or health-related field.
  • Extensive experience in clinical operations in medical devices, either with a medical device company or CRO.
  • Demonstrable leadership and project management skills.
  • Experience of working closely with Principle Investigators and building relationships with clinical trial site staff.
  • Masters/PhD degree in a scientific or health-related field.
  • Experience of set-up, management, and closeout of EU CE mark trials.
  • Experience of writing Clinical Evaluation Plans and Reports.

Why join Amber Therapeutics?

Amber Therapeutics is a pioneering medical device company developing a fully adaptive neuromodulation therapy to treat mixed urinary incontinence. As a Clinical Operations Manager EU, you will be part of a ground-breaking team creating life-changing therapies for millions of people globally. We offer a competitive salary commensurate with experience, private healthcare, income protection, life assurance, company pension scheme, and 27 days holiday (plus bank holidays). We celebrate diversity and are committed to creating an inclusive environment for all employees.



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