Clinical Research, Clinical Trial, Communication Skills, Documentation, GCP (Good Clinical Practices), ICH Regulations, Informed Consent, Maintain Compliance, Negotiation Skills, Organizational Skills, Performance Analysis, Performance Metrics, Problem Solving Skills, Process Management, Project/Program Management, Regulations, Startup, Team Player, Time Management
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.