New Position - Clinical Research Manager

At ev3 we’re committed to developing innovative endovascular technologies for coronary, peripheral and neurological applications. Creative, competent people with a passion for enhancing healthcare around the globe have driven our success. Join us as we grow by making a meaningful difference.   We are currently seeking a Clinical Research Manager. This position is responsible for managing and meeting the objectives of clinical studies, satisfying all applicable regulatory standards and company requirements. This position is able to handle the most complex clinical studies and is also able to provide mentoring to other members of the department This position is located at our manufacturing facility in Plymouth, MN.   We offer competitive compensation, generous benefits, and the opportunity to improve the lives of people everywhere. For consideration, please apply online at www.ev3.net. No phone calls please. Equal Opportunity Employer/ Affirmative Action Employer.



RESPONSIBILITIES: · Provides study management as Project Leader of key clinical trials and assures successful conduct of assigned clinical programs consistent with R&D and Marketing plans and applicable regulations and policies. This includes interfacing with representatives from key functional groups including: Clinical Affairs, Quality Affairs, Monitoring, Manufacturing, Sales, Marketing, Customer Service, Finance, Regulatory Affairs, R&D, and European Clinical Groups. · Works with Director of Clinical Affairs to develop department plan, objectives and trial needs assessment· Works with Director of Clinical Affairs to determine study objectives, strategy, scope and schedule in order to meet business needs. · Develops and maintains strong working relationships with Scientific Advisory Board members and key physicians providing input into clinical trial design and execution. · Develops and maintains strong working relationships with the Clinical Study team ensuring that the progress and status of the clinical trials is effectively discussed and communicated, and also providing leadership and serving as a role model. · Reviews and provides input on the Investigational Plan/protocol in consultation with the cross-functional project team, investigators and the clinical team. · Coordinates selection of PI’s and clinical sites. · Interfaces with, and assures training of investigators, site staff and ev3 Clinical Affairs staff. · Ensures the development, review and approval of case report forms (CRFs) for the clinical study.· Provides guidance to the Clinical Study Team in development of study materials such as patient brochures, patient recruitment materials, Manual of Operations, and Newsletters. · Interfaces with regulatory agencies as required· Ensures leadership and direction for DSMB/CEC meetings.· Assists in the selection and management of CRO(s) and core laboratories · Provides direction and oversees all outside CRO(s) associated with a trial to ensure adherence to contract, deliverables, data collection and other trial associated activities · Manages and mentors Level 1, 2, 3, and 4 department employees. · Enlists support and specifies tasks for various clinical team members to assure meeting study objectives on schedule. · Evaluates clinical data/information, convenes and directs investigator conferences to review findings and advise on direction. · Provides input and support for post-clinical activities and market launch of products. · Works with Clinical Study Team to ensure that all necessary information for post study reports and publications are provided. · Develops, manages and is responsible for budgets for assigned studies. · Provides leadership in one or more of the following areas: technical mentoring, supervisory/management, cost center management. · May require up to 40% travel – must be flexible with travel to meet needs of the study. · Acquire professional, product and market expertise via independent reading, networking and training. · Comply with applicable FDA and international regulatory laws/standards, the ev3 Code of Conduct, including company-wide and departmental Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs). · Other duties as assigned or required. MINIMUM QUALIFICATIONS: Education:

Bachelor’s degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field. Masters degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience Experience: · More than seven years experience directly supporting clinical research or similar experience in a medical/scientific area. Other skills: · Ability to work and form strong teams · High attention to detail and accuracy. · Advanced written and oral communications skills. · Able to manage multiple tasks · Proficient knowledge of medical terminology. · Expertise with GCPs and regulatory compliance guidelines for clinical trials. · High level critical thinking skills a must – ability to identify problems, identify impact and develop solutions · Knowledge of clinical and outcomes research study design, methods and statistics.