Founded in 2010, CryoTherapeutics is an early stage European innovator based in Awans. They develop a catheter for use by interventional cardiologists to treat atherosclerotic plaque that causes heart attack by delivering cryoenergy to the coronary arteries.
Cryo Therapeutics aims to develop and market the novel cryoenergy therapy initially for patients that have suffered a heart attack, and in the longer term also for patients identified by diagnostic methods as being at future risk of heart attack. For additional information about the company, please visit http://www.cryotherapeutics.com/
Late 2021, The Company closed about 12.3M€ which ensures great business ambitions thanks to strong international investors.
In order to support the expansion of the R&D team in Awans (Liège), we are looking for a (m/f) : Clinical Trial Project Manager.
Reporting to and working closely with the Director of Regulatory and Clinical Affairs, as Clinical Trial Project Manager, you are responsible for the operational management and the oversight of clinical trials according to the clinical strategy.
Your main responsibilities are :
- Support clinical trials, including set-up of clinical documentation (protocol, investigator’s brochure, clinical QMS), site selection and qualification of investigators, EC/CA submission and regulatory reporting.
- Facilitate and support staff for trial initiation, patient enrollment, compliance to the study protocol and use of the electronic database.
- Ensure that physicians and staff are well trained and educated , and assist in clinical cases.
- Ensure site monitoring, including scheduled visits, events reporting and documented interactions with clinical sites.
- Compile required clinical documentation for regulatory submissions.
- Work closely with the research team to ensure that all study procedures and visits occur as required in the protocol and timely entry of the data in the electronic database.
- Represent the company in all regulatory and third party audits for clinical activities.
- Deal with product-related site request and solve issues.
- Engage with physicians and clinical staff, build relations and credibility.
- Report results and work evolution on a regular basis to your line manager.
- Master’s degree in Biomedical Sciences, Bioengineering or any related field.
- 3-7 years as Clinical Research Assistant or Clinical Project Leader at country or European level.
- CRA/GCP training, preferably Medical Device GCP (ISO14155), and knowledgeable about regulatory requirements of medical device studies.
- Experience in clinical trials for cardiovascular medical devices and/or ability to manage cases in cath lab is an asset.
- Keen interest in scientific and technical issues related to clinical study.
- Ability to work and collaborate effectively with internal and external actors.
- Flexible, roll-up-sleeves attitude, self-directed and willing to travel when needed.
- 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.
Your application and related information will remain strictly confidential.