Do you want to see all aspects of clinical trial management and gain a lot of experience in a responsible and important role for your employer? In the Clinical Affairs Manager’s position you can take this chance of a relatively young and fast-growing company.
A medical devices company that has acquired a leading position for themselves in their home market in the wound market in the past 10 years. This challenging position in the clinical division is available at short notice. You can either be located in our client's office in Belgium (Kontich), in Luxembourg (Esch-sur-Alzette) or in Germany or UK (Home- Office based).
What will your job look like as Clinical Affairs Manager?
You do not directly manage a team. However, you have an independent role in which you interact with different departments, relying on regulatory and working closely with marketing colleagues. As Clinical Affairs Manager you mainly manage and coordinate the conduct of PMCF/clinical trials with a focus on medical devices. The planning, start-up, progress and closure of trials is familiar territory to you.
Furthermore, you will:
- Maintain quality and integrity of study data in accordance with protocol, company SOPs
- Work according to applicable laws (MDR/MDD), standards (ICH-GCP, ISO 14155) and guidelines
- Review, prepare, coordinate and follow-up CT submissions to ethics committees and competent authorities
- Assure that clinical trial projects are properly resourced, managed and executed according to established objectives, budget and timelines
- Manage the day-to-day clinical operations, including management of vendors (e.g. CRO) and coordination of activities
- Identify pro-actively project specific issues and set up strategies to handle this efficiently
- Support/lead of feasibility assessments and selection of countries and sites for clinical studies
- Collaborate proactively with the investigators/study team
As an ideal candidate your profile will read like the following:
- Msc or MD degree (pharma/biology/veterinary)
- You have at least 2-3 years of experience in the field of clinical affairs management for medical devices. A welcome combination with experience in pharmaceutical industry preferred.
- You have already been responsible for -or have supported- the conduct of clinical investigations/PMCF
- A must-have is experience with -and in-depth knowledge of - the applicable legislations of international markets and the necessary standards
- Your personality could best be described as a team worker who can work independently at the same time and who takes initiatives naturally. Problem-solver is your middle name!
- Excellent time management, presentation and interpersonal communication skills are important, when dealing with relevant authorities, consultants/CROs and experience in project management
- As you work in international working environment, fluency in English is required. Speaking German or Dutch would be a plus.
What does our client offer you?
Due to their success in the Belgian market, our client has expanded – and continues to do so- in The Netherlands, Luxembourg and Germany. There is room to grow along with the company and benefit from the flexible working culture of a young company. The culture can further be described as innovative and inspiring, with motivated employees that want to make an impact with the company’s products in their market. You will be able to do independent project work and share responsibilities within a professional team.
The company facilitates opportunities for learning and development, career building and offer a competitive remuneration according to experience.
You will report to the direct clinical line manager.
Are you interested in this position and fast-growing innovative company? Call Patricia Woestenburg on + 31 6 – 111 623 63.