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.