Clinical Research ManagerOcclutech is the leader in developing innovative products for the treatment of structural heart disease. The Company manufactures, develops, sells and markets Class III medical devices for the transcatheter repair of structural heart defects, including a range of specialized devices for patients with atrial fibrillation or heart failure, in over 80 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at www.occlutech.com.
Location: Istanbul, Turkey or Jena, Germany
Position Description:Occlutech seeks an energetic Clinical Research Manager. The successful candidate will be responsible for managing Occlutech’s clinical trials, patient registries, and all related activities in Europe, North America, China and elsewhere. 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 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 Company's sites. Moderate t travel is required.
- 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 to ensure the professional and timely execution of all clinical trial-related activities
- Manage and support the preparation of clinical data, clinical evaluations, as related to CE marking or international registrations
- Prepare, submit and coordinate clinical-related communications with Authorities, Ethics Committees and other relevant bodies
- Effectively represent the Company at key conferences and, together with Product Managers, support KOLs and conference presenters with clinical trial data, including reasonable analyses
- Collaborate closely with all functional areas necessary to aggressively advance clinical
development and post market clinical follow-ups
- Work according to Occlutech’s existing SOP's, guidelines, and protocols
- Provide regular updates to the COO and corporate management on clinical trial-related statuses, plans, budgets, timetables, and bottlenecks
- Minimum of 5 years of clinical trial experience gained in a similar position with at least 3 years in the cardiovascular device arena
- University degree from a top-tier academic institution in a relevant field
- 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.
- Collaborate closely with all functional areas necessary to aggressively advance products from proof-of-concept through validation and product launch, including Regulatory, Quality, Clinical & Marketing
- Proven experience of successfully directing the efforts of diverse teams located in multiple sites is required
- Effective team builder and problem solver, exhibiting a collaborative management style and the ability to bring out the best in people through example.
- Strong clinical and business mind; he/she should be able to visualize future strategy while also outlining and driving tactics to complete the milestones to successfully execute that strategy.
- Comfortable leading the execution of all aspects of clinical development including prioritization of projects
- General knowledge of ISO 13485, MDSAP & 21 CFR 820 quality system and work experience with nitinol or other, shape-memory materials a plus.
- Excellent communicator who radiates compassion, integrity and loyalty to Occlutech and its respective customers, partners, shareholders, and employees.
Application process:We look forward to receiving your application (cover letter, CV, qualifications and references -all documents in one pdf file),your salary expectation and the earliest possible date for start of work to firstname.lastname@example.org.
Only applications in English will be evaluated.
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