Study Start-Up Manager (Wilmington, DE)

Cedent; Wilmington (DE); On-site; USD 80,000 - 100,000; Full time

Job summary

A clinical research organization in Wilmington, DE is seeking a Study Start‑Up Manager to lead clinical study start‑up activities. The role requires extensive experience in regulatory processes, site management, and ensuring compliance with local and international guidelines, specifically ICH-GCP. The successful candidate will manage site regulatory documentation and collaborate with local teams to meet study milestones. This full-time position offers an opportunity to contribute to impactful clinical research.

Qualifications

• 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.

Responsibilities

• Lead and manage start‑up activities for clinical studies.
• Prepare, review, and track site regulatory documentation.
• Collaborate with Clinical Research Associates and local study team.

Skills

Clinical study start‑up experience

Communication skills

Organizational skills

Project management

Problem-solving abilities

Negotiation skills

Education

Bachelor’s degree in a relevant field

Tools

Veeva Vault

Job description

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.

Key Responsibilities

• 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).

Qualifications

• 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.