We are seeking a highly organised and detail-oriented GCP Document Manager to support the development, maintenance, and improvement of Standard Operating Procedures (SOPs) within Global Clinical Study Operations (GCSO) for a leading biopharmaceutical company in the Berkshire area. This role requires a proactive individual who can work both independently and in collaboration with cross-functional teams to ensure high-quality, compliant, and efficient processes across GCSO.
Review, revise, and improve existing SOPs to align with current practices, regulatory expectations, and operational needs.
Proven experience writing, revising, and managing SOPs—ideally within a clinical research, GCP, or related operational environment.
Understanding of clinical study operations—such as Data Management, Risk Management, or Data Standards—is beneficial but not required.
This is a manager-level role; Candidates seeking Quality Assurance auditor roles or coming solely from GMP/GLP backgrounds will not be a match—this role requires GCP and clinical study experience .