• The Project Manager serves as the Project Lead and primary sponsor contact and is accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. • Additionally, the Project Manager establishes and communicates customer expectations to the project team and ensures that escalation pathways are adhered to internally and externally. • The role involves leading the cross functional project team to meet or exceed deliverables. • Manages the day-to-day execution of assigned trials to ensure completion of established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. • Supports the Clinical Trial Lead in the development of specific study plans, development of core study documents, and systems set-up to ensure operational excellence in execution of the clinical trial protocol. • Develops required study specific training materials, including supporting the coordination of Investigator meetings. • Leads and chairs meetings with QSDO team members, including representatives from CTDU, CTAU and CSO to ensure the successful delivery of site activation and recruitment targets and evaluation recruitment strategies. • Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progress, issues, and risks to key SMT stakeholders during regularly scheduled meetings. • Depending on study needs, manage third-party study vendors including study specification creation, collection, and finalization in conjunction with the relevant functional SMEs. • Proactively identifies and resolves issues that arise during trial conduct, managing the escalation of trial-related issues. • Participates in and/or facilitates cross-functional collaboration and problem solving to ensure risk mitigation. • Supports the team to ensure timely data cleaning, data analysis and the availability of top line results. • Ensure project deliverables meet quality standards. • Ensures compliance with relevant sponsor policies and procedures. • Works with the Study Vendor Specialist to define project study specs during vendor setup. • Facilitate effective communication and collaboration among team members. • Adheres to project budgets, ensure timely billing and invoicing.

• Ensure smooth project delivery by managing scope, schedule, and budget while maintaining governance and quality standards • Oversee daily progress and coordinate cross-functional teams • Ensure client satisfaction through proactive communication and risk management • Track overall progress and highlight challenges to ensure risk-free delivery • Create budget, plans, and schedules to track project performance and issues

• The Project Manager (PM) is responsible for ensuring smooth project delivery by managing scope, schedule, and budget while maintaining governance and quality standards. • The PM oversees daily progress, coordinates cross-functional teams, and ensures client satisfaction through proactive communication and risk management.

• Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines • Serves as study lead and primary contact for sponsors • Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory • Generates and presents frequent study status updates and reports to sponsor • Supervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates • Supervises and trains Associate PMs • Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc • Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones • Ensures accuracy of reports and material work product • Provides monthly billing information to finance team • Presents at project meetings such as investigator meetings and new client meetings • Updates management accurately and regularly through frequent communication • Identifies issues and develops problem-solving strategies to ensure study timelines are met • Manages subject accrual, retention, and compliance • Assists in TMF management and manages TMF reviews as needed • Prepares for and participates in third-party audits and FDA inspections • Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs • Participates in internal, client/sponsor, scientific, and other meetings as required • Performs additional duties as assigned.