Clinical Site Start-Up Lead

Job Summary

A company is looking for a Clinical Site Identification and Start-Up Lead to oversee and manage the end-to-end process of site identification, selection, and start-up activities for clinical trials.

Key Responsibilities

• Lead the site identification and feasibility process for clinical trials, ensuring the selection of qualified sites
• Oversee site start-up activities including contract negotiations, regulatory document collection, and site initiation visits
• Continuously identify opportunities for process improvements to streamline site identification and start-up timelines

Required Qualifications

• Bachelor's degree in Life Sciences, Clinical Research, or a related field
• Minimum of 2 years of experience in clinical trials with a focus on site identification or start-up
• Experience with regulatory submissions and site initiation processes is essential
• Strong knowledge of clinical trial regulations and ICH-GCP guidelines
• Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) platforms