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- Tasks: Oversee clinical trials, ensuring safety and data quality in ophthalmology studies.
- Company: Join an innovative biotech focused on groundbreaking therapies for serious eye diseases.
- Benefits: Enjoy a flexible freelance role with the chance to make a real impact.
- Why this job: Be part of pioneering research that could change lives and advance your career.
- Qualifications: MD or equivalent with ophthalmology expertise, especially in wet AMD trials.
- Other info: UK-based candidates preferred for budget negotiations with study sites.
The predicted salary is between 72000 - 108000 £ per year.
About the CompanyOur client is an ambitious biotech developing novel therapies for serious ophthalmic diseases. Their program is entering its first-in-human clinical trial targeting wet age-related macular degeneration (wet AMD).Role OverviewWe are seeking a seasoned freelance Medical Monitor with deep ophthalmology expertise, ideally in wet AMD, to provide medical oversight, regulatory insight, and direct engagement study sites. The role involves close collaboration with investigators, budget teams, and internal stakeholders to ensure subject safety, high-quality data, and efficient trial execution.This is a hands-on position suited to someone comfortable working in a lean biotech environment and ready to influence decisions from protocol to final report.Key ResponsibilitiesServe as medical and scientific expert for the FIH ophthalmology study (wet AMD focus).Provide ongoing safety monitoring: review adverse events, eligibility queries, and safety data trends.Lead medical review of complex inclusion/exclusion cases and protocol deviations.Communicate effectively with investigator sites, addressing clinical queries promptly.If UK-based, take a leading role in budget discussions and contract negotiations with sites.Participate in Safety Management Team (SMT) and Data Safety Monitoring Board (DSMB) meetings.Provide strategic input into clinical trial design, protocol development, and amendments.Contribute to regulatory filings and submissions, including responding to health authority questions.Support medical sections of training materials for sites and study teams.Qualifications & ExperienceMD or equivalent with expertise in ophthalmology (wet AMD clinical trial experience strongly preferred).Track record as Medical Monitor or equivalent role in early-phase ophthalmology studies.Experience with regulatory submissions/filings in EU, UK, and/or US.Strong understanding of FIH trial conduct, GCP, and ICH guidelines.Demonstrated ability to work in fast-moving, small-company environments.Excellent communication skills; ability to liaise with global site teams.UK-based candidates strongly preferred (for budget negotiation with sites).
Interim Medical Monitor employer: LinkedIn
Contact Detail:
LinkedIn Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Interim Medical Monitor
✨Tip Number 1
Network with professionals in the ophthalmology field, especially those who have experience with wet AMD. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest developments in the industry.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for clinical trials in the UK and EU. Understanding these nuances can give you an edge during discussions with stakeholders and demonstrate your expertise in navigating complex regulatory landscapes.
✨Tip Number 3
Prepare to discuss your previous experiences in early-phase clinical trials, particularly any challenges you faced and how you overcame them. This will showcase your problem-solving skills and ability to thrive in a fast-paced biotech environment.
✨Tip Number 4
Highlight your communication skills by sharing examples of how you've effectively liaised with study sites or investigators in the past. Being able to convey complex medical information clearly is crucial for this role.
We think you need these skills to ace Interim Medical Monitor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in ophthalmology, particularly any work related to wet AMD. Emphasise your role as a Medical Monitor and any specific achievements in early-phase clinical trials.
Craft a Compelling Cover Letter: In your cover letter, express your passion for ophthalmology and the importance of the role. Discuss your understanding of the challenges in conducting FIH trials and how your expertise can contribute to the company's goals.
Highlight Regulatory Experience: Since the role involves regulatory insight, be sure to detail your experience with regulatory submissions and filings in the EU, UK, and US. Mention any specific instances where you successfully navigated regulatory challenges.
Showcase Communication Skills: Given the need for effective communication with investigator sites, provide examples of how you've successfully liaised with clinical teams or addressed complex queries in previous roles. This will demonstrate your ability to thrive in a collaborative environment.
How to prepare for a job interview at LinkedIn
✨Showcase Your Ophthalmology Expertise
Make sure to highlight your experience in ophthalmology, particularly with wet AMD. Be prepared to discuss specific cases or studies you've worked on, as this will demonstrate your deep understanding of the field.
✨Prepare for Regulatory Discussions
Since the role involves regulatory insight, brush up on your knowledge of EU, UK, and US regulatory submissions. Be ready to discuss your past experiences with these processes and how you can contribute to successful filings.
✨Emphasise Communication Skills
Effective communication is key in this role. Prepare examples of how you've successfully liaised with investigators and site teams in the past. This will show that you can handle clinical queries and foster collaboration.
✨Demonstrate Adaptability in Fast-Paced Environments
The company values candidates who thrive in lean biotech settings. Share experiences where you've had to adapt quickly to changes or challenges in a project, showcasing your ability to influence decisions effectively.
