Our client, based in the south of Luxembourg, is a company in the medical field. To strengthen its team, this firm is looking for a Clinical Affairs Specialist.
Your responsibilities :
- Support the preparation of the technical clinical documentation in accordance with the new MDR Guidelines (e.g., CER, CEP.…)
- Support Clinical trial protocols development and management of PMCF/clinical studies (Topical Medical devices as well as well as biological Pharmaceutical products and combination devices)
- Maintain quality and integrity of study data in accordance with company SOPs, applicable laws (MDR) and standard guidelines (ICH-GCP; ISO14155)
- Support review, preparation, coordination and follow-up of CT submissions to ethics committees and competent authorities
- Support the day-to-day clinical operations, including management of vendors (e.g. CRO) and coordination of clinical technical documentation activities
- Support/lead feasibility assessments and selection of countries and sites for clinical studies
- Proactive collaboration with investigators/study team
- Provision of feedback to the clinical line manager regarding study progress
Your profile and qualifications :
- You will hold a university degree in medicine/pharmacy/veterinary medicine/biology or other healthcare related university degree
- Knowledge of the European Union MDR Guidelines
- Knowledge of ISO 14155
- Experience with summary and analysis of clinical scientific literature
- Experience in clinical documentation in wound care or/and dermatology are an asset
- Knowledge of FDA Statutory provisions on Combinational and biological Products is an asset
- Experience with clinical statistical analysis is an asset
- You are fluent in English. Any other language is an asset.
- You are a motivated, hard-working and independent person.
- You are open-minded and solution-oriented.
Conditions and Advantages :
- Immediate start of work
- Pleasant working environment
- Young and dynamic team
- Multicultural environment
The candidates' career path :
- Analysis of your application
- Pre-interview with RH Lab (by phone)
- Interview at RH Lab.
- 2 interviews with our client
Applications sent directly to RH Lab.'s clients are systematically forwarded to us and result in additional processing time.Ref : ti37p2d317