Our client is a globally innovative designer, developer, and manufacturer of market-leading medical aesthetic devices and solutions that improve the well-being of customers all over the world. The business is currently undergoing significant and sustained growth with an increased global presence. In connection with this ongoing development, our client has identified a need for a motivated professional for the position of Senior Clinical Affairs Specialist.  

The Senior Clinical Affairs Specialist will have the responsibility for ensuring good communication and integration of all activities within the Clinical Affairs Department. The position will actively collaborate with the clinical evaluation process for the products to support Regulatory Affairs in the registration process. The Senior Clinical Affairs Specialist will be also responsible for providing support in clinical investigation and monitoring activities. He/she will be responsible for document and implement regulatory strategies in the support of international registrations.

The Senior Clinical Affairs Specialist will report to Clinical Affairs Manager, based abroad.

This position will work closely with all levels of the Clinical Affairs department as well as other departments including RDI, PMS, Legal, Compliance and Finance.

We will consider only CVs in English!

Responsibilities:

• Clinical Investigation and Monitoring:

• Developing and writing trial protocols, informed consents and support documents and presenting them to a steering committee;
• Designing data collection forms, known as case report forms (CRFs);
• Coordinating with the ethics committees;
• Identifying, selecting and working closely with an investigator who will be responsible for the conduct of the trial; Liaising with doctors/consultants or investigators on conducting the trial;
• Setting up and monitoring the trial sites; training the site staff to trial-specific industry standards; Identifying and assessing the suitability of facilities to be used as the clinical trial site;
• Monitoring the trial throughout its duration, which could involve visiting the trial sites on a regular basis;
• Collecting completed CRFs medical centres; Analysing results with a medical statistician, who usually writes technical trial reports;
• Closing down trial sites on completion of the trial; Archiving study documentation and correspondence; Preparing final reports and manuscripts for publication.
   

Regulatory Support:

• Preparation of Clinical Dossiers for registration (CER, Literature Reviews, Clinical Study Reports, and other related documents in accordance to European Regulation and according to corporate objectives
• Involvement in the development of procedures and standards aimed to improve and structure CA processes.
• Active role in searching, interviewing and following-up consultants required for medical writing, biostatistics, etc.
   

Requirements:

• Relevant university degree or postgraduate qualification (nursing, life sciences, pharmacy or medical sciences, etc.).
• At least 3 years of experience in similar positions.
• Excellent knowledge of European regulation is a must (Medical Devices CE & ISO 13485)
• Understanding the importance of good clinical practise (GCP).
• Experience with the regulatory process and clinical research
• Passion for science and innovations
• Good organizational and prioritizing skills
• Attention to detail and handling a lot of documentation.
• Advanced knowledge of English
• Computer literacy and the ability to quickly learn new computer programs.
• Readiness to travel.
   

The company offers:

• Flexibility to work remote
• Excellent salary and benefit package
• Mature and supportive Clinical affairs team to work with
• An entrepreneurial and innovative company with unparalleled high safety standards
• Remarkable growth of market share and still expanding