Clinical Project Manager
Vor 5 Tagen
We are epitome. A technology-based, dynamic company in Vienna. With our colorful team of experienced specialists, creatives and heroes, we are ushering in a new era and developing an outstanding smart/connected consumer product. Our approach is moving, innovative, a little crazy and always 100% goal-oriented.
As a Clinical Project Manager, you will plan and coordinate clinical investigations to assess the safety and performance of our innovative medical device.
**Furthermore YOU will be capable of varied fields of activities**:
- Planning, organizing, and direct activities of personnel involved in clinical research projects (CRAs, providers, etc.) to ensure that general clinical goals and objectives are met.
- Cooperation with authorities, ethics committees and similar institutions.
- Monitoring, tracking and reporting on the progress of delegated clinical investigations, and be responsible for all aspects of clinical studies, budgets and timelines.
- Selection and validation of vendors to guarantee the safety of patients, while complying with contractual agreements, procedures, and data integrity.
- Being contact person for KOLs & vendors, as well as internal departments and diverse study teams to ensure that clinical trials are conducted and executed effectively.
- Authoring, preparing and reviewing key clinical study documents including protocols, manuals, contracts, vendor budgets, and annual reports.
- Communication with shareholders and sponsors respectively.
- Support building and maintenance of our management system within the Health & Research Department.
**Now about you**:
- Your completed education in a life science field or an equivalent combination of education, training and experience is something you are proud of.
- You have at least 3 years of relevant professional experience as a CPM and previously as a CRA/Monitor in a CRO/medical device or pharmaceutical company, with experience in clinical research.
- You have in-depth knowledge and understanding of ICH/GCP and bring excellent knowledge and understanding of ethical and regulatory requirements.
- You have experience in drafting and handing in submissions to regulatory authorities and ethics committees.
- Good understanding of EU GDPR requirements can impress us; ideally you also have experience with ISO 13485 and MDR.
- Excellent written and spoken German and English skills make you stand out.
- Your knowledge of research methods lets you identify shortcomings of experiments and study designs.
- Your excellent administrative and sound time-management skills provide you with the ability to work in a highly accurate manner and let you meet project deadlines effectively.
- You have the ability to work independently while being part of an interdisciplinary team.
**Now about us - at epitome you can expect**:
- A dynamic, international working environment - with the opportunity to grow personally and take on responsibility
- An attractive salary starting at a minimum of EUR 3.500;
- gross per month on a full-time basis (unlimited employement) and the willingness to overpay with corresponding experience and qualification
- Daily fresh fruit and regular employee events
- An open and appreciative corporate culture with short communication and decision-making paths as well as room for own ideas
- Scope for success in a company full of winners and collegiality
- An interesting and varied field of activity
- A modern office with excellent transport connections in the heart of Vienna
- Unique team spirit
If you are looking for new challenges and the possibility of creating something new from the green field then let's get talking
**Join us**:
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