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.
Key Responsibilities
* Develop new SOPs and process documents that support GCSO operations and compliance.
* Review, revise, and improve existing SOPs to align with current practices, regulatory expectations, and operational needs.
* Lead and support process improvement initiatives across GCSO.
* Partner with cross-functional stakeholders to ensure SOPs accurately reflect workflows and responsibilities.
* Provide ongoing support for GCSO SOP governance, documentation updates, and operational processes.
Required Skills & Experience
* Proven experience writing, revising, and managing SOPs—ideally within a clinical research, GCP, or related operational environment.
* Ability to work independently, manage multiple priorities, and drive process improvements.
* Strong communication and collaboration skills, with experience engaging cross-functional teams.
* Understanding of clinical study operations—such as Data Management, Risk Management, or Data Standards—is beneficial but not required.
To ensure a strong fit with this position, please note the following:
* This is a manager-level role; it is not suited for candidates at Associate Director, Director, or higher levels seeking senior leadership positions.
* 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.
* Applicants without any exposure to GCP or clinical research environments will not meet the requirements.