CTI Clinical Trial and Consulting Services

• Selling CTI global central and bioanalytical laboratory services • Identifying, contacting and cultivating new clients • Serving as client manager for existing clients • Securing and maintaining relationships with qualified targets and decision makers • Developing and implementing specific disease strategies

• Review full computer system validation deliverables for regulated software, hardware, and laboratory instrumentation applications • Conduct internal audits related to validated systems and IT processes • Escalate unresolved observations to QA management • Conduct vendor audits of SaaS vendors • Prepare and distribute audit reports and assist with review of auditee response plans • Assist QA leadership team with review of non-conformance root causes and implementation of effective corrective actions • Maintain significant knowledge in global regulatory validation requirements • Prepare training materials related to global validation requirements

• Serve as the primary CTI Clinical Data Management (CDM) contact with sponsors and represent the DM group on CTI project teams • Responsible for study-specific CDM document development and maintenance, project status to the CTI project team, CDM management, and sponsors • Responsible for the data cleaning process from start-up through data archival, developing and/or approving project database builds, testing, and validation • Coordinate the receipt and processing of information for projects (e.g., coding dictionaries) as well as third-party electronic data utilized on projects

• Translate all documented customer expectations in the CTI Laboratory Services database to provide seamless services • Leverage technical, therapeutic area, client and CTI Laboratory Services process knowledge to provide a comprehensive review of the protocol • Liaise with internal departments along with the Laboratory Project Manager to understand CTI Laboratory Services capabilities and assess the feasibility of requests to meet client needs related to study design • Manage and solve technical changes, issues and concerns of high complexity work with little to no guidance • Displays strong interpersonal and communication skills that will build strong internal relationships to ensure high quality study design • Responsible for delivering quality technical services related to assigned clients. Ensure the consistent use of SOPs • Performs quality self-review in addition to review for other Study Designers when requested • Able to act efficiently in an environment with dynamic timelines and priorities • Displays appropriate self-organization and ability to manage conflicting priorities • Leads and participates in functional meetings and provides input, keeping processes up to date • Act as a Technical Expert by participating in process improvement initiatives • Other duties as assigned

• Serve as the primary CTI contact for assigned study sites • Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables to a high standard and within the timelines defined in the Monitoring Plan, while adhering to all applicable regulatory requirements, SOPs, and ICH-GCP • Assist with or oversee study start-up activities, including feasibility assessments, pre-study activities, and site selection • Collect, review and track essential and regulatory documents • Participate in and complete all general and study-specific training as required • Attend investigator, client, and project team meetings; may include giving presentations • Develop and implement subject enrollment strategies for assigned study sites • Ensure appropriate storage, dispensing, and accountability of all Investigational Product (IP) and trial-related materials • Perform site management activities and provide ongoing updates on site status to the Clinical Project Manager • Conduct remote monitoring and complete related activities in accordance with the study-specific Monitoring Plan • Use systems and reports to track subject status, CRF retrieval / source document verification (SDV), regulatory documents, and IP • Support project-specific activities as a member of the Project Team

• Overseeing and coordinating the operational aspects of safety/data monitoring committee projects ensuring quality, timeliness and client satisfaction. • Manage all phases of additional client projects from planning to completion. • Create timelines and project needs assessments. • Organize resources to develop the project, including multifunctional project team, budget, external vendors, etc.; manage timelines. • Produce or oversee timely production of quality deliverable, on budget. • Identify challenges that arise and propose effective solutions. • Oversight of final review and production of deliverables. • Provide project status reports to client and management. • Prioritize and manage resources to meet needs of several clients simultaneously.

• Perform medical monitoring activities under the oversight of a medical director • Medical monitoring activities include but not limited to review of the protocol and investigator’s brochure, review of medical budgets, preparing the medical monitoring plan, training project teams on the protocol, informing site identification and feasibility activities, supporting sites with clinical questions, participating in medical meetings, participating in medical and safety data review and analysis, and preparing and presenting data to internal and external stakeholders • Provide guidance to clinical teams on the medical and scientific aspects of assigned projects • Analyze and synthesize clinical information, participate in clinical problem-solving and clinical decision-making in the setting of clinical trials and studies • Lead and participate in medical data and safety reviews, including identifying critical safety trends and following up with sites/investigators to obtain additional information and to assess clinical events • Ensure patient safety and clinical trial integrity • Lead project-specific and department-wide organizational activities to optimize the efficiency and quality of medical services in Medical Affairs

• Provide independent leadership and oversight of complex, global clinical trials (Phase I–IV) • Serve as the primary senior‑level operational contact for clients • Own oversight of study budgets, scope, and profitability • Direct cross‑functional and regional teams to ensure consistent execution • Provide mentoring, guidance, and oversight to CPMs and other project team members • Contribute to broader organizational objectives through participation in business development activities

• Serve as main CTI contact for assigned study sites • Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP • Assist with study start-up activities, including feasibility, pre-study activities and site selection • Collect, review and track essential/regulatory documents • Participate in and complete all general and study specific training as required • Participate in investigator, client and project team meetings; may include presentations • Create and implement subject enrollment strategies for assigned study sites • Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials • Perform site management activities and provide ongoing updates of site status to Clinical Project Manager • Conduct remote monitoring and complete the related activities in accordance with study specific Monitoring Plan • Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP • Assist with project-specific activities as member of Project Team Monitoring Plan, etc. • Participate in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.) • Perform translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures • Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. • Provide regular updates to Sponsor/ Client • Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments • Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans • Identify and anticipate site issues and implement corrective actions or escalate as appropriate • Liaise with Clinical Data Management for data cleaning activities • Serve as mentor/trainer for CRAs; may include conducting training/assessment visits • Function in the role of Lead CRA for assigned projects(s)

• Serve as the senior representative for Japan, contributing to country strategy and representing CTI internally and externally • Build strong relationships with clients, sites/institutions, PIs, PMDA, vendors and partners • Provide leadership and oversight to Japan-based staff, supporting recruitment, onboarding, training, mentoring, and support country staff performance management • Represent Clinical Project Management services in client presentations and business development activities • Promote integration of Japan operations with regional and global teams, fostering collaboration and knowledge sharing • Serve as a senior liaison for Japan opportunities, supporting CTI BD Sales and Regional Operations leadership through strategic input on business development proposals • Develop and support marketing and branding initiatives in Japan, including representing CTI at industry conferences • Support the development and review of Japan-specific SOPs • Monitor the progress of all clinical trials in Japan • Ensure operational readiness, business continuity, and resource efficiency across Japan activities • Serve as the escalation point for Japan-based activities