We are seeking a highly experienced Clinical Operations Manager to lead and oversee Outside the U.S. (OUS) clinical operations, specifically across the UK and Australia/New Zealand (ANZ) regions.
This newly created position will play a key role in driving clinical trial excellence and accelerating enrolment across global sites, serving as the operational lead for all OUS activities and reporting to the Head of Clinical Operations (US-based).
Key Responsibilities
* Lead OUS Clinical Operations: Oversee all clinical activities across UK and ANZ sites, ensuring efficient enrolment, high-quality data, and compliance with regional regulatory standards.
* Site Engagement & Oversight: Maintain a strong operational presence at clinical sites, fostering close collaboration with Principal Investigators and site teams.
* Travel & On-Site Support: Spend approximately 3+ weeks per quarter in ANZ for on-site visits, plus travel to the U.S. as needed for meetings or study alignment.
* Regulatory & Ethics Reporting: Manage or oversee MHRA and REC submissions in the UK; provide oversight for ANZ regulatory and ethics processes.
* People Management: Line-manage two UK-based CRAs, supporting their performance, development, and day-to-day operational delivery.
Background & Experience
* Proven track record in clinical operations for medical device trials - ophthalmology experience is highly desirable.
* Experience with invasive medical devices or similar high-risk device studies.
* Strong understanding of UK and ANZ regulatory and ethics frameworks.
* Demonstrated line management and leadership experience.
* Ability and willingness to travel internationally (UK, ANZ, and occasional US).