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Job Details

Quality Control Representative (m/f)

Company: Chiltern
Location: Located in France or Spain
Reference: GQ900481
Closing Date: 16 Apr 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

For one of our clients, a pharmaceutical company with headquarters in Germany, Chiltern is looking for a Quality Control Representative (m/f). You can be based in Spain or in France.


Job Background

Chiltern, a global contract research organization, is a leading provider of clinical services and solutions in a variety of therapeutic areas with engagement models for biopharmaceutical and medical device industries. Chiltern’s team of more than 4,500, located across 47 countries, provides comprehensive Clinical Development, Medical & Scientific Affairs, Data & Analysis, Pharmacovigilance and Strategic Regulatory services using a collaborative approach for more efficient clinical trials. Visit to learn more about how Chiltern is Designed Around You®.

This position requires a strong clinical monitoring background and the ability to understand when appropriate escalation to management is required.


  • Oversee and evaluate the quality of the CRO and their CRAs in relation to site management and on-site monitoring
  • Ensure that clinical investigations are conducted in accordance with applicable SOPs, ICH/GCP and federal/local regulations
  • Review monitoring visit reports according to study requirements
  • Review electronic data entry by the site and cross-check this data with source data
  • Check daily alerts, where applicable, concerning the patients compliance during the study
  • Track site issues and resolution of action items
  • Attend CRO monthly CRA calls for Monitoring Plan Meetings to ensure awareness of problems encountered during site interactions
  • Attend weekly team calls with Clinical Project Lead as needed
  • Identify, together with Clinical Project Lead, in each country clinical sites for QC audit visit



  • Strong clinical monitoring experience, preferrably as a LCRA/SCRA
  • Good understanding of ICH/GCP and applicable local regulations
  • BSs/BA in scientific field or equivalent required or relevant experience
  • A minimum of 2 to 4 years in pharmaceutical and/or medical device industry, preferred, or relevant industry knowledge and experience to carry out the tasks as outlined
  • Excellent command of English (oral and written)
  • Proficient in MS Office, MS Excel, MS Access
  • Good communication skills
  • Ability to work with minimum supervision
  • Self-starter and problem solver
  • Detail-oriented




Position Type

Full Time


Email Gerda Quenum -

Apply for this job: Quality Control Representative (m/f)

Contact Information:

Address:  Germany
Norsk-Data-Strasse 1, 61352 Bad Homburg v.d.H. Germany

Tel:  +49 6172 9443 0
Fax:  +49 6172 9443 300
Website:  Visit Our Web Site

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