Clinical Researcher (Medior/Senior) Job in Eindhoven, Netherlands

Xelvin is a reliable partner for (international) companies to recruit and employ high educated technical professionals.

Our highly motivated employees are active in a broad variety of areas: mechanical, biomedical, electronic and chemical engineering, research and development, industrial automation and ICT.

Their flexibility and attitude make the difference. They have proven to be easy adapters and fast learners, they prove their productive value very fast.
Xelvin wants to achieve optimal added value for all parties involved. We help companies to find the right balance between their need for flexibility and finding the right person for the job ensuring continuity for the business. For employees we are looking for the most challenging jobs at the best companies in Europe.

Clinical Researcher (Medior/Senior) Job Description

Job description
As Clinical Researcher you will manage the Clinical Package preparation, conduct and close out of clinical trials in collaboration with our clinical advisory team. This position will compile information required for the clinical trial project including project timelines, resourcing, budget management, contract negotiation and finalization, and review and manage the of scope of work and change orders.
 
You will be responsible for preparing and finalizing key clinical documents which at minimum may include the clinical protocol, informed consent, case report form, and investigator's brochure as well as the investigational medical device dossier.
 
As a Clinical Researcher you will oversee internal conduct of study specific activities and be responsible for reviewing and approving final study reports to ensure that clinical trials are conducted meeting all applicable Regulations and Guidelines required. You will interface and cooperate with Research and Development and the Regulatory Team as well as the Clinical Investigators and CRO’s to ensure that regulatory requirements and company requirements are met. Upon study closure, you will have a leading role in writing of the Clinical Study Report (CSR).

 

Clinical Researcher (Medior/Senior) Job Requirements

Desired Skills and Experience

• Minimum of 2 years experience in clinical trials/research as CRM;
• Profound knowledge of GCP-guidelines and regulatory guidelines and directives that apply to clinical studies;
• Knowledge of medical device development processes;
• Working knowledge of relevant clinical support tools;
• Leadership and Stakeholder Management skills;
• Project management skills;
• Structure, accurate and pragmatic work approach and attitude;
• Team player and motivation skills;
• Flexible in working hours;
• Willing to travel;
• Excellent communication skills in English

Clinical Researcher (Medior/Senior) Application Information

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Clinical Researcher (Medior/Senior) Summary

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