Study Start-Up Manager

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 and site management.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.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 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.

Created: 2024-10-19