Study Start Up Manager
Join our Clinical Operations Team in a client-dedicated (FSP) role, supporting a leading global pharmaceutical company. This is a home-based position in the UK, where you will play a key role in driving global study start-up activities, site activation strategies, and operational excellence across international clinical trials.
This is an excellent opportunity for an experienced clinical research professional with a background in Study Start-Up, site activation, and regulatory submissions who enjoys working in a collaborative, fast-paced global environment.
What You'll Do
- Support and oversee Study Start-Up activities from site identification through site activation.
- Drive site activation timelines and proactively manage risks, escalations, and study milestones.
- Contribute to the development and execution of global Study Start-Up strategies.
- Coordinate regulatory submissions, Ethics Committee/IRB approvals, and site activation documentation.
- Collaborate with study teams, regulatory functions, external vendors, and other stakeholders to support successful trial delivery.
- Provide project updates and ensure timely completion of key deliverables.
- Support implementation of clinical systems, reporting tools, and process improvement initiatives.
- Contribute to the preparation and review of essential study documentation, ICFs, and regulatory submission packages.
- Ensure activities are conducted in compliance with ICH-GCP, local regulations, and company procedures.
What We're Looking For
- 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.
Preferred Experience
- 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.
Why Join Us?
- Dedicated partnership with a leading global pharmaceutical sponsor.
- Opportunity to influence global study start-up strategies and processes.
- Exposure to international, multi-center clinical trials.
- Collaborative and supportive team environment.
- Career growth opportunities within a global clinical research organization.
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