Study Start Up Manager

Job Title: Study Start Up Manager

Job Location: Maidenhead

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

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.

Learn more about our EEO & Accommodations request here.

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Originally posted on Himalayas