Serrix develops, registers and markets innovative consumer healthcare products. We are seeking a Clinical Research professional with relevant experience and ambition to grow this expertise in our organisation. This important and varied role involves both clinical research coordination for our consumer health (OTC) products and maintenance activities of our Quality Management System.
Serrix is an entrepreneurial company with a proven track record in the development and sales of innovative and effective OTC products. Our expertise lies in the field of product development, EU medical device registration and sales through our international distributor’s network in over 25 countries (EU & CIS). Serrix is located in the city centre of Amsterdam.
Preparing study synopsis for clinical trials related to medicated skin care or other Over-The-Counter indications, making summaries based on journals, preparing study design for different types of study and therapeutic areas, managing study budgets, preparing reports after a close out visit upon study closure. Your role, tasks and responsibilities will be:
- Preparing for Study Design for clinical trials, Clinical Investigation Protocol, and Investigator Brochures
- Identifying and channelling feasibility studies to potential principal investigators and Key Opinion Leaders (KOL)
- Assisting and preparing documents for Ethics Committee Submission for approval of Study Protocols and Investigator Brochures
- Preparing the Study Report based on Statistical Analysis obtained from the Statistician at the end of the clinical trials, as well as writing manuscripts for presentation and publication
- Ensure successful and high quality delivery of the study in accordance with ICH/GCP and in compliance with Medical Device Regulation
- Member of the QA/RA department and support maintenance of ISO 13485 based Quality Management System
- Negotiating and managing clinical trial budgets
We are seeking people with a high level of education (bachelors or masters title) and pragmatic personalities with a genuine interest for consumer health products. Profile we look for:
- 4 years+ hands-on experience in clinical research and understanding of quality management systems
- Good communication skills. Must be capable to develop effective relationship with principle investigators and competent authorities
- You are punctual and solution driven. You react decisive on actual changes and opportunities
- Experience or affinity working with start-up like environment
- Fluent written and spoken Dutch and English.
Being part of an informal result focussed team where ideas are valued and initiatives encouraged. Make things happen and you can look forward with as much confidence as we do. Serrix is an ambitious and dynamic company and is offering a challenging role, with lots of opportunities and competitive terms of employment in the field of consumer health products.
Have we sparked your interest? Would you like to join our team? Please send your resume to firstname.lastname@example.org.