An opportunity has opened for a Clinical Affairs Specialist to join a small Medical Devices company based in Frankfurt, Germany on a permanent basis. You'll be involved with conducting the clinical studies whilst working in a varied position where you'll also be involved with responsibilities such as PMCF study plans and reports for medical devices. This is a key hire in the Clinical Operations team which will be Perfect for a SCRA, Clinical Project Manager or experienced Clinical Operations professional with some medical devices/ medical writing experience who is looking to take the next step in their career.
My client is are a family run organisation with a strong financial backing who started 30 years ago. Due to the recent expansion of their pipeline (5 x products currently), they're looking to expand their team which is why this opportunity is open so it's an exciting time to join. You'll be working in a close knitted team whilst reporting into the Medical Director, so you'll have the chance to develop very quickly in this position up the career ladder.
My client is looking for someone to be office-based Frankfurt this opportunity with some flexibility to work from home so being locally based or being open to relocate for this role is essential.
A highly flexible basic salary (between 70k-90k EUR basic salary) + holidays, company pension scheme, individual training plans + corporate benefits is on offer.
Responsibilities:
- Planning and execution of clinical studies and evaluations.
- Preparation of clinical and biological evaluation plans and reports.
- Planning and monitoring of PMS and PMCF activities.
- Statistical evaluation of the study results.
- Creation of PMS reports (including PSUR) and safety reports (SSCP).
- Support activities in ??risk management.
Requirements:
- Studies in the field of medical technology or a scientific degree or comparable qualification.
- Experience in conducting clinical studies.
- Experience in writing medical texts, including clinical evaluation and clinical study reports.
- Knowledge of the regulations for medical devices (ISO 13485, ISO 14791, ISO 14155, MDR and MEDDEV and MDCG guidelines, 21 CFR 210/211 and FDA guidelines) are beneficial.
- Scientific degree.
If you are having difficulty in applying or if you have any questions, please contact Jack O'Neill at +44 203 846 0646.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-JO1
#ClinicalResearch
