Clinical Projects Manager - 727

Medinol is hiring a Clinical Projects Manager (global and local studies)!

Responsibilities:

• Managing and ensuring proper study during set up, conduct and close out of the study
• Oversight and Management of CROs in study set up, during study conduct and close out
• Reviewing monitoring reports and CRO’s other reports
• Managing qualification process of the sites
• Managing the preparation of study documentation, forms and the development of administrative systems and processes
• Managing and tracking the study submission process to ECs and regulatory authorities

Qualifications:

• Bachelor’s level degree or higher degree (Para-medical, Life sciences, pharmacist, or related field)
• At least 2 years’ experience as Clinical Project Manager
• Experience from pharmaceutical industry or medical devices companies
• Knowledge of cardiovascular field and/or interventional cardiology- an advantage
• Experience in large scale (i.e. phase III) or foreign clinical studies- an advantage
• Self-training capabilities
• Good training skills (in English)
• Excellent communication skills (oral and written)
• Good negotiation capabilities (CRO’s and sites budget)
• Strong organizational and interpersonal skills
• Regulatory knowledge. Knowledge of foreign regulatory guidance’s (Medical device) –an advantage
• Excellent knowledge of Microsoft Office programs
• English –proficient (High level writing skills)

About the company…

Medinol is dedicated to the science of cardiovascular intervention. For over 25 years, we have delivered over two million coronary stents to patients worldwide. Our products constantly stretch the limits of innovation and our cutting-edge technology continues to demonstrate extraordinary clinical results. We make our products in-house using proprietary manufacturing technologies that ensure consistently exceptional quality and safety. Medinol manufactures EluNIR™, the first elastomeric drug eluting stent. Now FDA approved and CE marked, EluNIR demonstrated excellent clinical outcomes and promising safety profile in two clinical studies and features the Flexx² catheter technology with a metallic spring-tip, resulting in unprecedented ease-of-delivery even in tough anatomies. A unique stent design provides low metal footprint and optimized vessel support, leveraged by an elastomeric coating that ensures excellent surface quality. Founded in 1992 by Dr. Judith Richter and Dr. Kobi Richter and privately held to this day, Medinol continues to benefit from the leadership and insight of its founders. With more than 300 employees on board, we proudly maintain our family spirit and entrepreneurial culture.