Offre d'emploi : Clinical Trial Assistant (M/F)
Miracor Medical is a European medical device company specialized in improving the clinical outcome of patients with impaired cardiac function (specifically acute myocardial infarction), active in interventional cardiology. The company has developed a high potential class III proprietary technology that consists of hardware, software and catheter(s).
The technology is well-advanced in a randomized clinical trial in ST-Elevation-Myocardial Infarction (STEMI) patients, with various potential additional therapeutic applications (among others, high-risk PCI, NSTEMI and heart failure). The company has received in 2020 CE Mark for its proprietary catheter and console and expects approval from FDA to run a pivotal Investigational Device Exemption (IDE) study in 2021. Miracor has received Breakthrough ('fast track’) designation from the FDA in 2019. During 2021, Miracor will initiate the commercialization of its products.
Miracor Medical (www.miracormedical.com) 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 near Liege.
In order to strengthen the team, we are looking for a (m/f):
Clinical Trial Assistant
Reporting to the VP Clinical Affairs, the Clinical Trial Assistant (CTA) is responsible for the coordination and execution of operational aspects of clinical trials in conjunction with Clinical Study Manager and project team and in accordance with standard operating procedures (SOP), good clinical practice (GCP), specific country regulations.
The main position’s responsibilities are:
- Contribute to the Company Quality Objectives (QMS-POL 0003).
- Track, update and maintain clinical study documents on the shared study folders (inhouse).
- Develop and maintain Trial Master File and study trackers to ensure completeness for audit/inspection readiness and contribute by performing ongoing quality checks/review.
- Prepare the ISF (investigator site file) for the initiation of new sites in a clinical study.
- Assist in clinical study logistics (e.g. shipments of clinical trial materials).
- Assist in tracking the oversight of a clinical study.
- Prepare the clinical trial budgets.
- Organize the study meetings (internal and external).
- Assist Clinical Affairs Manager and Clinical Research Associate in day-to-day management of the clinical study.
- Asist in general or country specific study document preparation (ICF and other) for ethics committee or regulatory authority submissions.
- Assist in the development of study plans.
- Other duties as assigned by direct Supervisor.
- You have a bachelor or a master’s degree in life science, or equivalent through experience.
- You have at least 2 years of experience in clinical trials, CRA experience and/or experience in medical devices.
- You are fluent in English. Good knowledge of any other language is an asset.
- You have knowledge of ICH-GCP guidelines (accredited GCP course desirable) and ISO14155: 2020.
- You are a team player, flexible, proactive, able to manage multiple tasks and capable to work with limited supervision.
- You pay strong attention to details, you have a problem-solving mindset and you are highly adaptable to change. You also have and excellent communication skills.
- A challenging and diversified position within a high-potential fast-growing 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.
Send your CV together with a short cover letter via https://www.pahrtners.be/en/jobs/clinical-trial-assistant-mf-en/ or to email@example.com.
Your application and related information will remain strictly confidential.