Job Summary

A clinical research organization needs applicants for an opening for a Remote Senior Clinical Document Manager.

Candidates will be responsible for the following:

• Acting as key business partner and primary liaison with global Translation vendor to establish streamlined process workflows
• Devising strategy for central development and translation of key country and study documents
• Maintaining up to date regulatory authority/ICH-GCP knowledge to ensure documents remain compliant

Qualifications Include:

• Meets with CDO end users regularly to review document library and discusses issues or concerns
• 8 years of Pharm/industry experience
• 5 years of relevant clinical operations experience and 2 years of Study Manager
• 4 year degree is required
• Study Start Up experience required
• Ability to work cross functionally and abililty initiate and lead team/project to achieve desired results