Clinical Site Manager (Study Start Up for NPC)
On-siteMotherwell, Scotland, United Kingdom or Burgess Hill, England, United Kingdom
Job Summary
Lead end-to-end study start-up activities by driving site identification, selection, and activation to ensure clinical trials launch efficiently and are compliance-ready. Manage Ethics Committee and Competent Authority submissions, ensuring all trial documentation, local contracts, and institutional approvals meet stringent regulatory timelines. Act as the primary contact for assigned study site personnel, coordinating necessary certifications and developing critical study documentation including informed consent documents and patient instruction guides. Collaborate cross-functionally with global, local, and virtual teams to deliver top-tier clinical diagnostic solutions while fostering inclusive team environments across diverse regions and time zones.
Required Qualifications
- A degree in a scientific discipline or related field (or equivalent combination of education and experience)
- A proven track record in clinical operations or clinical trial coordination
- Hands-on experience navigating diagnostic and medical device trials
- Experience managing Ethics Committee (EC) and Competent Authority (CA) regulatory submissions
- Strong understanding of In Vitro Diagnostic Medical Device frameworks and Medical Device Regulations
- Knowledge of global standards such as ICH-GCP guidelines
- Exceptional verbal and written communication skills (English)
- A proven ability to build trusted relationships and influence cross-functional partners
- Proactive, collaborative, and highly organised clinical research professional
- Strong problem-solving skills
- Ability to make sound independent decisions
- Ability to excel at managing external vendor relationships
- Ability to thrive in a fast-paced, matrixed environment
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.