Study Start-Up Manager

Job Summary: Join our team as a Study Start-Up Manager, where you will play a crucial role in leading global study start-up and site activation activities for Phase I-III and real-world evidence clinical trials. You will collaborate closely with CROs, study teams, vendors, and investigative sites to ensure the timely, high-quality, and compliant achievement of start-up milestones. In this position, you will provide strategic oversight and hands-on support, guiding efforts from early study planning through country and site selection to data-driven scenario planning and enrollment forecasting, ensuring predictable delivery of clinical projects. The Study Start-Up Manager will be responsible for the end-to-end delivery of global study startup activities. This includes the development of global study startup plans in partnership with CRO Study Startup teams, driving efficiencies to boost internal start-up capabilities, and facilitating operational planning to achieve R&D goals effectively. Key Accountabilities: Lead global study start-up and site activation activities, ensuring milestone oversight and CRO performance. Develop comprehensive global study startup plans through effective collaboration with the CRO Study Startup team. Enhance internal start-up processes to align with Trial Delivery Optimization goals. Guide study teams through critical startup activities to ensure timelines align with operational planning and decisions. Work with internal feasibility experts to deliver accurate study startup forecasts and planning. Engage in strategic global study planning to ensure timelines for study start-up and site activation are realistic and achievable. Partner with CROs to ensure streamlined startup processes and deliver best practices for country and site activations. Collaborate with study team members and CRO counterparts to progress site activations, addressing issues promptly to facilitate activation. Monitor and report on KPIs and metrics related to cycle times to support process improvement and operational reporting. Ensure consistent application of study start-up standards and processes to maintain high-quality, cost-effective clinical studies, adhering to local regulations. Build and maintain best practices for study start-up and site activation. Support inspection and audit readiness through compliance with GCP, SOPs, and regulatory standards. Contribute to continuous improvement initiatives, enhancing study start-up efficiency through tool and technology adoption. Skills & Requirements: Bachelor's Degree in Science or a related discipline is required. 5-7 years of clinical research experience in a CRO or pharma organization, with proven involvement in leading global study start-up and site activation. Proven experience overseeing CROs on multinational clinical studies. Strong understanding of study start-up processes including feasibility assessments. In-depth knowledge of ICH/GCP and clinical development processes, including study conduct, start-up, feasibility, and recruitment strategies. Exceptional organizational, communication, and problem-solving skills with a demonstrated ability to manage competing priorities. Ability to build strong relationships with CROs, vendors, and cross-functional partners. #LI-CF1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Created: 2026-03-10