Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company sells and markets ASD, PFO, PLD and PDA occluders, as well as a range of specialized occlusion devices and accessories in over 50 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at www.occlutech.com .

Clinical Research Manager (m/f) REPORTS TO: Chief Operating Officer POSTION LOCATION: The successful candidate will be based in Jena, Germany

POSITION DESCRIPTION:

Occlutech is expanding its clinical trial team and seeks an energetic Clinical Research Manager. The successful candidate will be responsible for managing Occlutech’s clinical trials, patient registries, and all related activities. Specific tasks include planning, preparing, managing, monitoring, and budgeting the Company’s clinical trial activities; coordinating CROs; interacting with clinical investigators; training of site-staff; and preparing submissions to Competent Authorities in Occlutech’s markets. To this end, the Clinical Research Manager will be working together with R&D, Regulatory, and Quality professionals at the Companys sites. Significant travel is required.

PRINCIPAL RESPONSIBILITIES:

• Plan, prepare, manage, monitor, and budget all clinical trial & related activities
• Manage CROs, effectively collaborate with clinical investigators and trial site staff, collaborate with R&D, Regulatory, Quality and other departments at Occlutech to ensure the professional and timely execution of all clinical trial-related activities
• Support preparation of clinical data as related to CE marking or international registrations
• Prepare, submit and coordinate communications with Competent Authorities, Ethics Committees and other relevant bodies
• Work according to Occlutech’s existing SOPs, guidelines, and protocols
• Provide regular updates to the COO and corporate management on clinical trial-related statuses, plans, budgets, timetables, and bottlenecks

REQUIREMENTS:

• 5 years of clinical trial experience gained in a similar position with 3 years in the CV medical device arena
• University degree
• Extensive knowledge of relevant government regulations, standards and guidelines
• Strong analytical and problem solving skills & excellent interpersonal and communication skills & team player
• Proven track record of working in a dynamic, international environment
• Excellent written and spoken English

APPLICATION PROCESS:

Applicants must provide a CV & cover letter stating their interest in the position and their qualifications. Only English-language application will be considered.

Occlutech GmbH
att: Katrin Biedermann
Wildenbruchstraße 15
D-07745 Jena
katrin.biedermann@occlutech.com
phone: +49(0)3641-675120
www.occlutech.com

Bitte geben Sie bei Ihrer Bewerbung folgende Referenznummer an: JD-504295