Study Start-Up Manager (Wilmington, DE)

We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site management, and expertise in ensuring compliance with local and international guidelines, particularly ICH-GCP.
 

• Lead and manage start-up activities for clinical studies, ensuring compliance with local and international guidelines (ICH-GCP).
• Prepare, review, and track site regulatory documentation throughout the study start-up phase.
• Collaborate with Clinical Research Associates (CRAs) and the local study team to meet start-up milestones.
• Participate in Local Study Team meetings and report on site performance metrics.
• Ensure the timely submission of documents to regulatory authorities and maintain the trial master file (eTMF).

• Minimum 3 years of experience in Clinical Study Start-Up (full-time).
• At least 1 year of hands-on experience with Veeva Vault.
• Strong background in informed consent review and negotiation.
• Bachelor’s degree (higher degree preferred) with knowledge of clinical trial processes (Phases II-IV) and ICH-GCP.
• Excellent communication, organizational, and project management skills.
• Strong problem-solving and negotiation abilities.

Department: Direct Clients
This is a full time position