Clinical and Regulatory Documentation Manager

Posted 10 March by LinkPoint Resources Limited

We specialise in the recruitment of high quality candidates with expertise in Clinical and Regulatory Documentation. We have an excellent opportunity for an Administrator to join a global biotechnology / pharma company based in Cambridge.

Core Duties

The provision of administrative support for the company’s regulatory documentation management and for internal and external staff and company contracted clinical research organisations.

Key skills and knowledge

  • Understanding of global regulatory requirements and guidelines for conducting clinical trial and clinical research.
  • Knowledge of relevant GCP, external and internal regulatory requirements/guidelines
  • Project Management/planning experience
  • Ability to collaborate and build relationships to maximize organizational function and capabilities

Qualifications Required

  • Masters Degree OR
  • Bachelor’s Degree & 2 years directly related experience
  • Associates Degree & 5 years of directly related experience
  • High School diploma / GED & 8 years of directly related experience

Desirable Qualifications:

  • BS/BA/BSe in the sciences or RN
  • 2 years Clinical Documentation Management and industry experience (e.g. CTA/CRA/Study Manager) in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.

Are you enthusiastic about this job? Send us your CV in word format today

Required skills

  • Clinical Research
  • Document Management
  • Regulatory Requirements
  • Degrees
  • Administration

Reference: 34654499

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