We are currently looking for a Clinical SOP Specialist to join a leading Pharmaceutical company in the Berkshire area. As the Clinical SOP Specialist you will be responsible for writing Standard Operating Procedures for including but not limited to Clinical site management, study plans, Study management, informed consents and clinical data management. This is an initial 12 month contract with likely extension. This role can offer 3 days per week of remote working, with 2 days per week onsite.
Key Duties and Responsibilities
- 1. As the Clinical SOP Specialist you will support the development and maintenance of the quality management system and compliance infrastructure for global clinical sciences and operations. Create Standard Operating Procedures for including but not limited to Clinical site management, study plans, Study management, informed consents and clinical data management.
- 2. As the Clinical SOP Specialist you will partner with global quality, regulatory affairs, clinical strategic partners and other stakeholders to maintain compliance with Good Clinical Practice (GCP), International Council for Harmonisation guidelines and applicable local and international regulations. Provide guidance across clinical study phases, investigate complex compliance issues, and prioritise mitigation and escalation according to compliance and patient safety risks.
- 3. As the Clinical SOP Specialist you will understand clinical site management and ideally have clinical operations experience.
Role Requirements
- 1. Relevant degree, alongside extensive pharmaceutical and clinical quality management experience. A background in clinical site management and clinical operations is particularly relevant.
- 2. Proven industry experience in writing standard operating procedures SOPs and experience of Good Clinical Practice (GCP).
- 3. A working knowledge and practical experience with Good Clinical Practice (GCP), international regulatory guidelines, quality systems and risk-based decision-making. Fluent spoken and written English, effective planning and project management, and strong presentation, training and influencing skills will support your work with colleagues, partners, vendors and senior leaders across a global environment.
Key Words
- Clinical Quality
- Process Quality Excellence
- Good Clinical Practice
- Quality Management Systems
- Clinical Operations
- Standard Operating Procedures
- Corrective and Preventive Actions
- Regulatory Intelligence
- GCP
- Clinical site management
- study plans
- Study management
- informed consents
- clinical data management
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.
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Clinical SOP Specialist employer: Hyper Recruitment Solutions Ltd
Join a leading supplier of analytical and testing equipment that values innovation and collaboration, making it an excellent employer for a Materials Characterisation Technical Sales Specialist. With a strong focus on employee growth, you will have access to ongoing training and development opportunities while working in a dynamic team environment that encourages creativity and strategic thinking. The flexibility to work remotely across the UK allows for a healthy work-life balance, making this role not just a job, but a meaningful career path in a thriving industry.
Contact Details:
Hyper Recruitment Solutions Ltd Recruitment Team
