项目启动经理

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.

This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Originally posted on Himalayas