Clinical Operations and Process Specialist
Company: Planet Pharma Agency
- Location: Slough, United Kingdom
- Seniority: Senior
- Employment type: Contract
- Posted: Yesterday
- Offer language: English
Job description
🚨 Clinical Operations and Process Specialist (Clinical SOPs & QMS)
Are you the person everyone turns to when a clinical SOP needs writing, updating, or improving?
We're supporting a global biopharmaceutical organisation that is significantly expanding and revising its Clinical Operations Quality Management System. As a result, we're looking for an experienced Senior Process Quality Excellence Specialist to take ownership of SOP development and process documentation across a global clinical environment.
This is a highly focused role where approximately 90% of your time will be dedicated to SOP authoring, revision, and quality process documentation, making it ideal for someone who genuinely enjoys process improvement, quality systems, and translating regulatory requirements into clear, practical procedures.
What you'll be doing
✅ Writing, reviewing and updating clinical SOPs and associated quality documents
✅ Supporting the development and maintenance of a global Clinical Quality Management System (QMS)
✅ Creating and revising procedures covering areas such as:
- Study management
- Site management
- Informed consent processes
- Clinical study plans
- Operational quality processes
✅ Partnering with Clinical Operations, Regulatory Affairs, Quality and key stakeholders to ensure GCP compliance
✅ Driving process improvements and helping shape best practices across a global clinical organisation
✅ Providing guidance on GCP requirements and clinical quality standards
Please note: audit and inspection activities are not a significant part of this opportunity.
What we're looking for
✔ Strong experience writing and revising SOPs within a regulated clinical environment
✔ Solid background in Clinical Operations, Clinical Quality, or Clinical Compliance
✔ Excellent understanding of GCP, ICH guidelines, and clinical trial processes
✔ Experience working within Quality Management Systems (QMS)
✔ Ability to translate complex regulatory requirements into clear, user-friendly procedures
✔ Prior experience supporting global clinical studies and operational processes
Nice to have
➕ Experience with Veeva QualityDocs/QMS
➕ Experience with process mapping tools such as iGrafx
(Training can be provided if you haven't used these systems before.)
Why apply?
This is a rare opportunity to join a globally recognised life sciences organisation in a role where you'll have genuine influence over how clinical quality processes are designed, documented, and maintained across international studies.
📩 Interested? Apply now or contact me directly for a confidential discussion.
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