Study Start Up Manager

Role: Lead country-level clinical trial start-up activities, focusing on site activation, regulatory submissions, and operational efficiency to accelerate trial timelines and ensure compliance with ICH-GCP and local regulations. Responsibilities include managing regulatory documentation, leading ethics submissions, coordinating with sites and cross-functional teams, and maintaining data integrity within clinical systems like CTMS and eTMF. The role involves overseeing informed consent processes, negotiating language with sites, and monitoring start-up milestones to mitigate risks. Requirements: Bachelor's degree, 3+ years in clinical study start-up, with hands-on experience in Veeva Vault, site negotiations, and start-up processes across Phases II–IV. Strong communication, organization, project management, and vendor management skills are essential. Preferred: multi-country and multi-therapeutic area experience, familiarity with eClinical tools, and additional language skills. The position is geared toward experienced professionals capable of leading complex, fast-paced start-up operations. The work setup is not explicitly specified but involves collaboration with global teams, with a focus on operational excellence and speed to site activation, ultimately supporting the delivery of clinical trials that bring new medicines to patients faster.