Study Start Up Project Leader - FSP

The Study Start Up Project Leader is responsible for formulating, developing, and executing the global strategy for study start-up by collaborating with various teams including Global Study Start-Up Operations, Clinical Development & Operations, Global Regulatory Submissions, and others as necessary. Assigned to one or more interventional studies across diverse therapy areas such as oncology, vaccines, internal medicine, rare diseases, or inflammation and immunology, the Project Leader typically oversees the activation of investigative sites until they are prepared to enroll participants, although this role may extend into the participant recruitment phase to manage protocol amendments at active sites for designated studies. The Project Leader possesses extensive knowledge of coordinating and managing global study start-up activities. Project Management: Collaborate with country/site feasibility specialists to assimilate up-to-date intelligence regarding planned countries and sites into the comprehensive start-up strategy and site activation plan. Work alongside teams handling regulatory submissions (both local and country level) and start-up functions (such as site essential document gathering, contracts, and budgeting) to synchronize activities and ensure a robust start-up strategy and site activation plan. Continuously evaluate current and upcoming workloads with other study start-up leaders to proactively anticipate, troubleshoot, and request the necessary adjustments to the assigned team for timely site activations. Manage coordination with various roles at the study and country level to monitor progress on study-specific tasks (like vendor setup, investigational product supply) or country-specific tasks (like regulatory submissions, importation of supplies) essential for site activation. Oversee project management activities that directly support all site activations within the study management-led team responsible for completing all start-up activities. Lead start-up meetings to align site selection with activation activities, utilizing an ongoing risk assessment to maintain focus on achieving major study milestones (e.g., first subject first visit) as well as the overall target for site activations. Work with on-ground start-up teams to identify opportunities for accelerating site activations while considering the priority of the study relative to other concurrent studies. Plan Delivery: Accountable for the quality and completeness of start-up timeline plans at the study, country, and site levels within an enterprise project management system, either directly or through oversight of other roles. Responsible for constructing and overseeing the initial baseline and periodic updates to timeline planning within the enterprise system to establish targets for site activation. In conjunction with study management roles, ensure equitable participant compensation for sites involved in multiple concurrent studies to prevent overlaps in compensation impacts. Integrate the requirements of protocol amendments to ensure site activations proceed as planned, managing the approval of sites for implementing these amendments post-activation. Responsible for reaching site activations to plan, whether for all sites in a study or a subset in specific regions. Ensure the completeness and quality of the site activation timeline for each investigator from the initiation package to full site activation. Risk Mitigation: Work across the study team and extended partners to ensure site activations occur as planned, evaluating ongoing readiness and proactively identifying and mitigating risks. Serve as a key escalation point for site activation related issues, resolving issues directly or reallocating them appropriately, ensuring thorough follow-through to resolution. Skills: Exposure to country or regional start-up processes across at least two major therapeutic areas. Technical expertise in utilizing software for clinical study management, with strong skills in reporting systems for status communication. Ability to employ basic generative AI techniques in daily operations. Use standard risk management methodologies for identifying and addressing risks. Fluency in English is essential. Knowledge and Experience: Substantial global start-up clinical trial management experience. Thorough understanding of Good Clinical Practices, monitoring, and regulatory operations. Extensive knowledge of clinical trial methodologies. Proven start-up experience. Demonstrated project management expertise. Education: A scientific or technical degree is preferred. Must hold a BS/BA with 5 years of relevant experience or an MS/PhD with 3 years of relevant experience. #LI-REMOTE Parexel embraces diversity and is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.

Created: 2026-03-10