Getting a great idea to market takes a lot of work, some luck and a very careful planning of resources. Clinical trials, specifically, require all of these, and a special addition of creativity and flexibility. I am a problem solver and a scientist, dedicated to, and passionate about getting results and successfully navigating your device through the challenges of the clinical phase.
I am a well-rounded clinical trials operations manager and have worked in the biomedical industry for some 15 years. I have held positions from clinical trials manager at a pharmaceutical company, through building and growing a clinical trials department at a biostatistics company and to various positions as a clinical director in medical device startups. I have experience both as an independent contractor as well as a full-time employee in the Israeli medical device industry – both startup companies and corporates.
I bring not only expertise and experience in the management of clinical trials.
I also bring outstanding communication skills with the R&D team and QA personnel of the company, understanding of the entire device development process, a profound joy and passion in what I do, and above all – the true understanding that no two clinical trials are ever the same. That allows me to succeed in completing clinical studies within budget, timelines and according to strategic plan and milestones, time after time.
Are you a CEO of a medical device startup and this is your first clinical trial?
Are you an experienced manager in the industry and have come across a clinical challenge?
Is your clinical trial already ongoing but recruitment is slow and the investigators unresponsive?
Planning a clinical trial in a territory you are unexperienced with?
What do I provide? My main service is ease of mind! Successfully planning and executing clinical trials is one of a company’s greatest challenges, requiring endless amounts of decisions and posing a huge burden on the company and all its departments. Assuming responsibility on every single aspect of the clinical trial, whether it is First In Human or a Pivotal study, while becoming one of your team, provides you confidence and ease of mind.
Design of clinical trial protocols, Investigator's Brochure or any other essential document
Compilation of submission packages for clinical trials
Selecting investigators, sites and territories for clinical trials
Ongoing consultancy and problem solving during the conduct of a clinical trial
Design of a clinical trial report (CSR)
Assistance in subject recruitment, communication with investigators, unresponsive or non-cooperative sites
Assistance with problematic or challenging submissions
Assistance in expediting study timelines
General consultancy on clinical trials