The Company is currently seeking a Clinical Research Manager which will be located in Europe. Reporting to the company R&D manager, the Clinical Research Manager will be responsible for clinical operational oversight and execution (initiation, enrollment, and completion) of the medical device clinical trials. The Clinical Research Manager will manage the assigned clinical trial(s) in adherence to Good Clinical Practices as applicable under the regulatory agency(ies) governing the study, and any other applicable guidelines and regulations.
This position requires strong leadership skills and the ability to manage people, meet clinical project goals and timelines, and align with company initiatives.
Main Responsibilities
Responsibility for new studies with the company product: site selection and installation, materials, submissions, contracts, EDC, etc. Manage and provide accountability for the day-to-day operations of the study, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations. Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable. Serve as primary Sponsor contact for operational project-specific issues and study deliverables. Maintain in-depth knowledge of protocol, therapeutic area, and indication. Establish strong relationships with site investigators and other KOLs. Conduct periodic site visits (engagement and management). Qualifications
Bachelor's degree in a health-related field; Advanced degree in a health-related field preferred. 3+ years of experience in the medical device arena. 3+ years of Clinical Affairs/field clinical specialist experience. Familiarity with catheter lab/operation room environment. Experience with a mid-scale US or EU Pivotal Trial. Excellent written and oral English communication skills. Good organizational and technical skills. CT reading / ECG analysis – an advantage. Overseas travel up to 20%. Personal Skills:
Excellent communication, presentation, interpersonal, and problem-solving skills. Ability to work independently as well as collaboratively in a start-up environment. Ability to work under time and pressure constraints. #J-18808-Ljbffr