Home - Maya Shick

Don't think outside the box.

In clinical trials, there is no box.

Maya Shick

Owner

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.

Services

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?

If your reply to any of these questions is "yes",
I am here to help.

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.

Don't need full planning and execution? I will be happy to help with any of the following:

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

Recommendations

"Maya offers professionalism, profound knowledge and substantial experience. Maya's creative way of thinking allowed us to perform the clinical study in the fastest, most efficient way, while meeting the company's budget and timelines. Maya's work is accompanied by establishing fruitful and pleasant working relationships with both company personnel and professional personnel outside of the company".

Avner Geva, CEOVensica Medical

"Maya has extensive experience in clinical trials management with exceptional performance. Maya was responsible for managing the clinical activities in the company (including study design, allocation of hospitals and supervision of the clinical personnel). Maya demonstrated extensive knowledge with a professional way of thinking and a very positive attitude which contributed to the successful fulfillment of her Job. It was a pleasure working together."

Lior Margalit, CEOOmeq Medical

"Maya supported our clinical operations in its initial stages. Maya has been available for any question, task or request and completed the tasks under her responsibility thoroughly and professionally, and has always been willing to promote the company's goals and assist wherever possible. It was a pleasure working with a consultant that takes into consideration all aspects of the project and offers a unique and flexible point of view."

Omri Naveh, CEOEngo GI Medical

"Maya joined Nitiloop as a sub-contractor to conduct and manage an international clinical study in USA and Europe. Although working in a partial time in the company, Maya was a full colleague and friend in the company. The challenging task was performed by Maya in an admirable fashion with a great success while keeping both the quality, the timely execution and great inter-personal relation with hospitals, physicians, regulatory and company colleagues. On top of that, Maya completed the clinical study report finalized in a clean and fast FDA clearance."

Amir Pansky, CEONitiloop