Clinical Study Specialist

Clinical Study Specialist (CSS)

📍 Hybrid (3 days/week in office) – Armonk, NY | Cambridge, MA | Warren, NJ | Uxbridge, UK | Dublin, Ireland

Shape the Future of Clinical Research

Are you passionate about advancing clinical trials and making a real impact on patient outcomes? We’re looking for a highly organized, detail-driven Clinical Study Specialist (CSS) to support the execution of innovative clinical programs across global teams.

In this role, you’ll be at the operational heart of clinical trials—collaborating with cross-functional teams, supporting study execution, and ensuring everything runs smoothly from start-up through close-out.

What You’ll Do

As a Clinical Study Specialist, You Will

• 📊 Deliver clear, actionable reports and metrics to support study oversight
• 📅 Coordinate and manage clinical study team meetings (agendas, materials, minutes)
• 🔍 Support feasibility assessments and site selection activities
• 📄 Assist in the review and management of key study documents (ICFs, CRFs, etc.)
• 📚 Maintain study manuals, reference binders, and version-controlled documentation
• 🎓 Prepare materials for investigator meetings and training sessions
• 🚀 Track site activation, enrollment, and monitoring progress—flagging risks early
• 🌐 Maintain investigator/site data and support clinical trial registry updates
• 🗂️ Reconcile and maintain Trial Master File (TMF) documentation
• 🤝 Coordinate with sites, vendors, and internal stakeholders
• 📈 Contribute to data review processes, including Blind Data Review Meetings
• 🔄 Track study close-out activities and ensure compliance
• 💡 Identify and recommend process improvements
  
  

Note: Up to 25% travel may be required.

What You Bring

Required

• Bachelor’s degree (or equivalent) with 2+ years of relevant industry experience OR advanced degree with 1–2 years of experience
• Strong attention to detail and ability to manage multiple priorities
• Excellent communication and relationship-building skills
• Problem-solving mindset with a proactive approach
• Familiarity with clinical development processes and medical terminology
• Working knowledge of ICH/GCP guidelines
  
  

Technical Skills

• Experience with clinical systems (CTMS, EDC, IWRS/IVRS)
• Proficiency in Microsoft tools (Teams, Office, Project, SharePoint)
  
  

Why Join Us?

• 🌍 Work on global, impactful clinical programs
• 🤝 Collaborate with experienced and supportive teams
• 📈 Grow your career in a fast-paced, innovative environment
• 🧠 Contribute ideas that shape processes and improve outcomes
  
  

Ready to Make an Impact?

If you’re a proactive, detail-oriented professional who thrives in a collaborative clinical environment, we’d love to hear from you.

👉 Apply now and help bring life-changing therapies to patients worldwide.

#kpslife