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Genentech USA3 weeks ago

Clinical Site Manager

On-site · Sant Cugat del Vallès, Catalonia, Spain

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Large

Job Summary

Clinical Site Manager responsible for designing, planning, coordinating, initiating, monitoring, and completing clinical research studies at designated clinical sites. Acts as the primary site contact and trial expert, coordinating training and certification, conducting site assessments and activations, managing documentation (Study Monitoring Plans, informed consent, source documents, patient instructions, case report forms), overseeing CROs and cross-functional collaboration, and delivering site management activities across start-up, conduct, and close-out for registrational and non-registrational studies. Requires a Bachelor's degree in Science and 3 years in Medical Device/Diagnostics with 2 years in clinical study experience, especially in cardiovascular/metabolic areas and Near Patient Care or Point of Care; strong knowledge of ICH GCP and regulatory requirements; capable of working in a fast-paced, matrixed environment with diverse, global teams.

Required Qualifications

  • Bachelor’s degree in Science (Health Sciences like Clinical Diagnostics or engineering) or equivalent
  • 3 years in Medical Device or Diagnostics
  • 2 years in clinical study of IVD/Medical Device/Drug
  • experience in cardiovascular/metabolic indication and Near Patient Care or Point of Care
  • ICH GCP knowledge
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Genentech USA

Clinical Site Manager

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