Clinical Affairs Specialist - M/F - open-ended contract

Publiée le 16/03/2021

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RH Lab.


Temps de travail
Type de contrat
Expérience professionnelle
Niveau d'étude

Société

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.

Mission

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

Profil

 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
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RH Lab.

Rue de l'Industrie
4823 Pétange
Luxembourg

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Clinical Affairs Specialist - M/F - open-ended contract

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Clinical Affairs Specialist - M/F - open-ended contract

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