Study Start-Up Manager; Wilmington, DE

Study Start‑Up Manager with extensive experience to lead clinical study start‑up activities. 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.