~6mo ago

Study Start-Up Manager (Wilmington, DE)

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Quick Summary

Overview

function googleTranslateElementInit() { new google.translate.TranslateElement({pageLanguage: 'en'}, 'google_translate_element'); } Study Start-Up Manager (Wilmington, DE)…

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.

Requirements Summary

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.

Technical Tools

gcpproject-management

Summary

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.

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

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