Study Start Up Manager
RemoteMaidenhead, England, United Kingdom
Maidenhead, England, United KingdomRemoteFull TimeSenior LevelBachelors DegreeSmall
Full TimeSenior LevelBachelors DegreeSmall
Job Summary
Oversee Study Start-Up activities from site identification through activation, driving timelines and managing risks across international clinical trials. Coordinate regulatory submissions, Ethics Committee approvals, and documentation while collaborating with study teams, vendors, and stakeholders to ensure trial delivery. Implement clinical systems, reporting tools, and process improvement initiatives in full compliance with ICH-GCP and local regulations. Provide project updates and maintain operational excellence within a client-dedicated global environment.
Required Qualifications
- Bachelor's degree in Life Sciences or a related field
- 5+ years of experience in clinical research, Study Start-Up, site activation, regulatory affairs, or a related area
- Strong understanding of clinical trial conduct, including global and multi-center studies
- Experience with site activation activities and regulatory submissions
- Solid knowledge of ICH-GCP guidelines and regulatory requirements
- Proven project management and stakeholder management skills
- Excellent communication, organizational, and problem-solving abilities
- Fluent English
Desired Qualifications
- Working across multiple countries and regions within a global clinical trial environment
- Partnering with cross-functional teams and external service providers
- Supporting process improvement and operational excellence initiatives
- Experience with CTIS, Ethics Committees, Regulatory Authorities, and clinical systems used to support Study Start-Up activities
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