Study Start-Up Manager

Job Summary: Join our dynamic team as a Study Start-Up Manager, where you will play a key role in guiding global study start-up and site activation efforts for Phase I-III and real-world evidence clinical trials. You will collaborate with Clinical Operations teams, CROs, study teams, vendors, and investigative sites to ensure seamless, timely, and compliant attainment of start-up milestones. Your expertise will be critical in overseeing all aspects of study initiation, from early study planning to enrollment forecasting, assuring effective and consistent project delivery. The Study Start-Up Manager will adeptly balance strategic oversight with hands-on involvement, supporting various initiatives such as feasibility assessments, regulatory submissions, and site activation while actively pursuing process enhancements and sharing best practices across our organization. You will create actionable project plans, implement best-in-class processes and technologies, and drive timely problem resolution, enabling study sites to activate efficiently and meet corporate objectives. Key Responsibilities: Oversee global study start-up and site activation activities while ensuring milestone tracking and CRO performance. Develop a comprehensive global study startup plan in collaboration with the CRO Study Startup team. Enhance internal operational efficiencies to align with our Trial Delivery Optimization goals. Guide study teams in executing key startup activities within set timelines that contribute to operational planning and decision-making for predictable project delivery. Engage with internal Feasibility experts to provide rapid and accurate study startup forecasts, ensuring data-driven assumptions and scenarios. Participate in strategic, early global study planning sessions to align study start-up goals with corporate objectives. Partner with CROs to ensure effective startup processes and reporting for successful country and site activations. Collaborate closely with internal teams and CRO counterparts to advance site activations efficiently and overcome site-level challenges. Monitor and report on relevant KPIs and metrics to support continuous process improvement and enhance site activation timelines. Ensure adherence to study startup standards and compliance with operational, legal, and regulatory requirements, delivering high-quality clinical studies. Develop and maintain best practices for study start-up, country, and site activation. Support audit readiness by ensuring compliance with GCP, SOPs, and regulatory standards. Contribute to ongoing improvements in tools, technologies, and knowledge sharing to boost study start-up efficiency. Qualifications: Bachelor's Degree in Science or a related discipline. 5-7 years of clinical research experience in a CRO or pharmaceutical organization, with direct experience in global study start-up and site activation. Proven experience overseeing CROs on multinational clinical studies. Strong understanding of start-up processes, including feasibility assessments and site selection. Knowledge of ICH/GCP and broad experience in clinical development, including trial conduct, study start-up, feasibility, and patient recruitment strategies. Exceptional organizational, communication, and problem-solving skills, with a demonstrated ability to manage competing priorities. Proven ability to build strong partnerships with CROs, vendors, and cross-functional teams. #LI-CF1 #LI-REMOTE EEO Disclaimer: Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Created: 2026-03-04