Study Start-Up Manager

Responsibilities

• Clinical Operations leadership role with project responsibilities and accountability in the delivery of Study Start-Up (SSU), initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, SOPs, and local regulations
• Ensures SSU clinical trial activities are executed to expected and specified timelines and quality standards
• Monitors start-up metrics and compliance with CTMS business rules and global eTMF standards
• Responsible for managing and addressing SSU performance
• Actively drives best practices and process improvement to optimize efficiencies in delivery
• Leads team in achievement of study, departmental, and organizational goals by providing guidance, support, and development opportunities
• Demonstrates mastery of skills required to conduct SSU activities from selection through activation
• Manage SSU resource allocations and conduct ongoing assessments to ensure balanced workload for quality delivery
• Provide country-specific SSU expertise to project teams
• Competent in communication and influencing skills to ensure timely follow-up, risk mitigation, issue resolution, and updates to teams
• Manage and maintain local SSU tools and resources
• Familiar with ICF GCP, relevant country regulations/guidelines, and SOPs
• Facilitate SSU Forum discussions
• Support in resource forecasting activities
• Contribute to the development of local workflows to streamline output and deliverables
• Line Management
• Interview and onboard new hires; ensure ongoing training compliance
• Conduct regular 1:1s to assess workload, provide guidance and feedback, develop team
• Conduct mid-year and year-end performance check-ins and reviews

Qualifications

• Bachelor\'s degree or higher in a scientific or healthcare discipline preferred
• Minimum of 5 years progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, or CRO environment
• Knowledge in the execution of clinical trials, understanding of ICH/GCP
• Effective prioritization in the achievement of goals
• Strong written and verbal communication skills
• Highly organized
• Diligence in follow through
• Two years of management experience
• Line management experience
• Functional Service Provider model knowledge and/or experience
• Mentoring and training team members