Miracor Medical is a class III medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).
The technology is in advanced clinical stages, with various potential therapeutic applications (among others acute infarct and heart failure).The company aims at getting CE Mark and approval from FDA to run a pivotal study in the next 3 years.
Miracor Medical offers a culturally diverse English-speaking working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities. The offices are based in Awans.
In order to strengthen the team, we are looking for a (m/f):
Clinical Study Manager
As Clinical Study Manager and reporting directly to the Clinical Affairs Director, you play an important role in the operational management of the clinical studies. You plan, execute and manage clinical projects and provide guidance to internal and external stakeholders.
Your main responsibilities are:
- You supervise and organize clinical project(s) and program(s) in Europe, in collaboration with internal and external partners.
- You ensure that assigned clinical study project(s) are managed in respect of established timelines and quality and regulatory standards.
- You develop and manage study-related documents and necessary structures for efficient running of clinical studies.
- You deal with product-related site request and solve issues.
- You ensure that all necessary ethics committee and hospital approvals are obtained.
- You provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents.
- You author Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents.
- You are the point of contact for CRAs and coordinate support needs for the sites.
- You train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.
- You manage clinical trial adverse event and device deficiency workflows.
- You report results and work evolution on a regular basis to your line manager.
- Bachelor’s or master’s degree in Biomedical Sciences, or equivalent through experience.
- At least 10 years’ experience in clinical study management at country or European level for medical devices, ideally cardiac implantable devices.
- Qualified knowledge of Medical Device Regulations on conduct of clinical investigations (ISO14155, GCP, EU MDD, EU MDR)
- You are able to understand and interpret medical device regulations and standards and apply them in a practical and consistent manner.
- You have strong knowledge and understanding of clinical research context and related documents.
- You are autonomous and have a hands-on and pragmatic mind-set.
- You are able to work and collaborate effectively with internal and external actors to achieve company objectives.
- You are fluent in English. A good command of French and other languages is an asset.
- Proficiency with common business software, such as MS Office applications.
- A challenging and diversified position within a high-potential innovative medical device company.
- To work in a human size, dynamic, respectful and professional environment.
- International exposure, with learning and development opportunities.
- An attractive compensation package in line with the position responsibilities and your experience.