Lead and coordinate study start-up/site activation across countries, guide site activation specialists, develop country-specific ICFs, use data/forecasting to drive timelines, mentor team members, identify process improvements, and escalate/resolves start-up delays to achieve Ready-to-Enroll status.
Fortrea is looking for an experienced Study Start-Up Lead to join our sponsor-dedicated team. If you enjoy leading study start-up activities, working with global teams, using data to drive smarter decisions, and helping clinical trials move forward efficiently, we'd love to hear from you.
As a Study Start-Up Lead, you'll play a key role in ensuring clinical studies are activated efficiently and ready to enroll participants on time. You'll work closely with cross-functional teams, provide guidance to site activation specialists, and help shape study start-up strategies across multiple countries.
Your responsibilities will include:
- Leading and supporting site activation teams across global clinical programs.
- Partnering with Clinical Operations teams to improve study start-up performance and timelines.
- Using data, forecasting tools, and industry insights to support planning and decision-making.
- Developing country-specific Informed Consent Forms (ICFs) based on local requirements and approved templates.
- Identifying opportunities to streamline processes and drive continuous improvement.
- Monitoring study progress, proactively addressing potential delays, and escalating issues when needed.
- Providing mentorship and guidance to study start-up team members.
- Collaborating with internal stakeholders to ensure sites achieve "Ready to Enroll" status as efficiently as possible.
- Acting as a key point of contact for study start-up challenges and helping teams find effective solutions.
- Bachelor's degree in Life Sciences or a related field (or equivalent experience).
- 4+ years of experience in clinical operations, study start-up, project management, or trial optimization.
- At least 2 years of hands-on experience managing site activation and study start-up activities within a CRO or pharmaceutical environment.
- Experience creating country-level Informed Consent Forms (ICFs).
- Strong analytical skills with experience using data, forecasting tools, and performance metrics.
- Ability to interpret complex information and communicate it clearly to a variety of audiences.
- Solid understanding of the factors that contribute to successful study start-up and site activation.
- Previous experience working in a global clinical research environment is highly desirable.
- Strong communication, organizational, and stakeholder management skills.
- Be part of a global team committed to improving patient outcomes through clinical research.
- Work in a collaborative and supportive environment where your ideas are valued.
- Influence the success of international clinical trials and help bring new treatments to patients faster.
- Take ownership of meaningful projects and contribute to process improvements on a global scale.
- Enjoy opportunities for professional growth and career development within a leading CRO.
Join Fortrea and help shape the future of clinical research while working on studies that matter!
Learn more about our EEO & Accommodations request here.
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