Clinical Study Manager Remote 3908-1

The Study Specialist supports clinical study activities, focusing on site management, problem solving, and ensuring compliance in rare disease clinical trials.

Location: Morristown, NJ

Responsibilities

• Support site start-up, maintenance, and close-out activities.
• Identify and resolve site issues, motivate and educate site staff.
• Liaise with sites, sponsors, and CROs to ensure site readiness and recruitment.
• Manage multiple academic sites, ensuring patient safety and data integrity.
• Support inspection readiness and regulatory documentation.
• Complete training and adhere to departmental objectives.
• Lead or facilitate meetings to share project/site knowledge.

Requirements

• Bachelor’s Degree in Life Science or RN preferred.
• Minimum 5 years of study management experience, preferably in Rare Diseases.
• Experience in on-site monitoring and complex hospital-based Phase 3 trials.
• Knowledge of FDA regulations, GCPs, and study protocols.
• Strong problem-solving, communication, and computer skills.
• Willingness to travel up to 50%.

Additional Information

• Position reports to the client Clinical Operations Study Team Lead.
• Supports all site management activities including regulatory and safety reporting.
• Experience in rare diseases like Sickle Cell Disease is preferred.