I have managed multiple clinical trials across various phases, ensuring adherence to GCP, FDA, and ICH guidelines. My approach involves meticulous documentation, regular audits, and close collaboration with regulatory affairs to stay updated on changes. I also conduct thorough training sessions for the team to ensure everyone understands and follows the protocols.

I prioritize immediate documentation and communication with all stakeholders. My strategy includes assessing the impact, implementing corrective actions, and ensuring the trial can proceed without compromising data integrity. I also involve regulatory bodies if necessary and update the trial protocol to prevent future occurrences.

I implement rigorous monitoring plans, including frequent site visits and data reviews, to ensure patient safety. I also emphasize thorough informed consent processes and maintain strict data entry protocols to prevent errors. Regular training and clear communication with the study team further enhance data integrity.

I start by creating a detailed budget and timeline based on the trial's scope and requirements. I monitor expenses closely and adjust the plan as needed to stay within budget. Regular progress meetings with the team help identify potential delays early, allowing for timely adjustments to keep the trial on track.

I have extensive experience in selecting sites based on their capability to meet trial requirements, including patient recruitment potential and regulatory compliance. I establish strong relationships with site personnel, conduct regular monitoring visits, and provide ongoing support to ensure they adhere to the study protocol and meet recruitment targets.