Clinical Study Start-Up Lead

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

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.