Our client is a 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 stage, with various potential therapeutic applications.
You are looking for a professional challenge that allows you to work in a fast-moving and clinical stage company in order to work on Medical Devices Projects?
After a strong experience as CRA, you want to endorse new responsibilities as Clinical Study Manager? Thanks to that operational experience of Clinical activities you want to bring your expertise to a more helicopter level?
Plus One can offer you this great challenge:
Your key responsibilities:
• You support 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 will co-monitor or monitor clinical data at the sites as needed.
• You work closely with the CRAs and the research teams at the sites 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.
• 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.