Founded in 2009, CryoTherapeutics is an early stage European innovative company that is now establishing its operations in Awans (Liège). The company is in the process of developing a novel catheter system to treat atherosclerotic plaque that causes heart attacks by delivering cryoenergy to the coronary arteries. For additional information about the company, please visit http://www.cryotherapeutics.com/
CryoTherapeutics aims to develop and market the novel cryoenergy therapy initially for patients who have suffered a heart attack, and in the longer term also for patients identified as being at future risk of heart attack. CryoTherapeutics recently raised 7M€ in its latest round of financing and will use these funds to continue development of this technology with the aim of starting clinical studies later this year.
In order to support the expansion of the team in Awans, we are looking:
Clinical Research Associate/Manager
Reporting to and working closely with the Chief Medical Officer, as Clinical Research Associate/Manager, you are responsible for the operational management and the oversight of clinical trials according to the clinical strategy.
Your main responsibilities are :
- Support and manage clinical trials for company, including protocol writing, clinical investigation reports, site selection and qualification of investigators.
- Facilitate and support physician training for initiation of the trial, Site Initiation Visits, patient enrollment according to protocol inclusion criteria and site monitoring.
- Assist in clinical cases and ensure that physicians and staff are well trained and educated with regards to patient selection, treatment planning, optimum use of system, etc.
- Site monitoring, including scheduled visits, events reporting and documented interactions with clinical sites
- Compiles required clinical documentation for regulatory submissions including patient consent forms, contracts and monitoring plans.
- Work closely with the research team to ensure that all protocol required procedures and visits occur according to protocol specified guidelines and timely entry of the data in the electronic database.
- Represent the company in all regulatory and third party audit requests for clinical trial information.
- Deal with product-related site request and solve issues.
- Engage with physicians and clinical staff, build relations and credibility to be a high level spokes partner.
- Create and maintain effective partnerships with KOL.
- Report results and work evolution on a regular basis to your line manager.
- Master’s degree in Biomedical Sciences, Bioengineering or any related field.
- 4-7 years minimum in the management of pre- and post-market medical device studies (class III) at country or European level.
- Experience in clinical trial protocol writing, support for cardiovascular medical devices, and ability to manage cases in cath lab.
- Experience introducing disruptive technology, which somehow changes the way clinicians operate.
- Experience in directing, training physicians and staff to stand-alone level.
- Flexible, roll-up-sleeves attitude, self-directed and willing to travel frequently.
- Keen interest in scientific and technical issues related to clinical study.
- Ability to work and collaborate effectively with internal and external actors to achieve company objectives.
- Excellent oral and written communication skills in English. Any other language is a plus.
- Up to 30% travel may be required.
- A challenging position with a high potential innovative medical device company.
- To work in a human-sized, collaborative and respectful environment
- A variety of interesting contacts with international exposure.
- An attractive compensation package in line with the position’s responsibilities and your experience.