Senior Clinical Project Manager

About Occlutech

Occlutech is a leading specialist provider of minimally invasive cardiac devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a global leading specialist provider in cardiac devices, addressing congenital heart defects, stroke prevention, and heart failure. Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200 patents with more than 190,000 products sold. The company markets and sells its products in over 80 countries and has around 330 employees.

About the position

The Clinical Project Manager will plan, prepare, and manage all monitoring-related activities, the performance of monitoring of trial/registry sites

A young and motivated team will welcome you to meet together the challenges of clinical research. After an introduction period, you will have freedom for self-organization to fulfill your tasks. We also offer opportunities for further professional development.

Your work will focus on

• Conduct clinical trials, clinical studies, and registries according to all applicable regulations, commonly accepted practices, and to Occlutech's internal guidelines, i.e.

o Prepare Essential documents according to ISO 14155, MDR

o Care for submission approvals by Competent Authorities and favorable opinions by responsible Ethics Committees

o Plan and track the course of the studies and update tracking lists

o Liaise with study investigators and site staff on a regular basis

o Oversee and lead subcontractors such as, but not limited to, data management, local monitors

• If required, assist in Study audits
• Main line of communication between investigators / site staff and Occlutech
• Provide regular updates to CRM on trial status, plans, and bottlenecks
• Contribute to Occlutech QM system (e.g., preparing SOPs)
• Perform other related duties and responsibilities, on occasion, as assigned

We are looking for a candidate, who

• Has a university degree (min. Bachelor) preferably Master's degree in life science or engineering or natural sciences
• A minimum of 3 years' experience in the field of clinical research
• Knowledge of relevant government regulations, standards and guidelines
• Knowledge of Medical Device Regulation (MDR)of
• Strong analytical and problem-solving skills & excellent interpersonal and communication skills & team player.
• Proven track record of working in a dynamic, international environment
• Proficient user of computer applications, software's for the execution of daily project operations
• Experience on using on Clinical trial management system (CTMS) or equivalent
• Ability to travel when it is needed
• Excellent written and spoken English.
• Excellent written and verbal communication skills are required. Demonstrated proficiency with ICH, and GCP,ISO is required.

Our benefits

• A secure job in the medical device industry in a family-friendly working environment
• An interesting work scope in a growing international company
• Comprehensive onboarding and training plan in the first 6 months
• Good work-life balance through 30 days of vacation, flexible working hours and hybrid, family-friendly working time models
• Employer-financed retirement insurance
• Team building, employee and company events
• Easy access to the office on the Beutenberg Campus with an attached canteen
• Healthy work culture with a fruit basket, tea, water and coffee as well as regular team sporting events

Ready to apply?

We look forward to receiving your application (cover letter and CV to .

Only applications in English will be evaluated.

Contact

Kristin Spanka | People & Culture Business Partner

Telephone

Occlutech GmbH Winzerlaer Strasse Jena