What are the responsibilities and job description for the Study Start-Up Manager (Wilmington, DE) position at CEDENT?
Summary
Qualifications
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).
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
