• Ensures the implementation of clinical trials in compliance with standards • Acts as primary site contact and manager throughout clinical research phases • Develops strong site relationships • Performs site management and monitoring activities • Participates in site selection and qualification activities • Conducts site visits and prepares reports in a timely manner • Communicates with investigators and site staff • Manages documentation in CTMS, eTMF, and other systems

• Oversee clinical trials, ensuring successful execution from start-up to close-out. • Lead site selection and feasibility assessments, working closely with CRAs and investigators. • Manage study timelines, budgets, and deliverables, ensuring adherence to project objectives. • Provide oversight on protocol administration, site initiation, monitoring, and study progress. • Collaborate cross-functionally with internal and external stakeholders, including sponsors, investigators, and project teams. • Ensure compliance with GCP, FDA regulations, and company SOPs. • Train and mentor CRAs and site staff, ensuring protocol adherence and data integrity.

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. • Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters. • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. • Participates and presents in key meetings such as Kick Off Meeting. • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. • Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. • Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. • Ensures access and audit trail reviews are conducted as required. • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. • Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. • Document requested revisions and approvals in CTMS. • Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. • Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. • Provides solutions for obstacles in protocol execution and site management. • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. • Supports Inspection Readiness for clinical trial management scope. • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. • May develop and support execution of corrective action plans at site and study level. • Supports and completes activities to achieve data cut and lock deadlines. • Provides feedback to line managers on staff performance including strengths as well as areas for development. • May be assigned to larger, more complex trials.

• Provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. • Works with confidential subject and company data, and interfaces with a variety of internal and external stakeholders. • Develops/maintains project timeline inclusive of startup through completion. • Drives development, approval, and distribution of study-related documents and study tools for investigational sites and review committees. • Manages distribution, collection and tracking of regulatory documentation to help ensure audit readiness. • Negotiates study budgets with sites, Core Labs, and other vendors. • Attends site visits as necessary. • Contributes to process improvements that help foster continuous improvement. • Helps update and maintain study trackers and dashboards. • Participates in system user acceptance testing. • Manages vendors such as Core Lab. • Organizes and manages Investigator Meetings. • Works with data management to develop systems for and track project metrics. • Drives development, approval, and distribution of study-related documents including Case Report Forms and study manuals. • Monitors progress of studies, identifies study-related trends/issues and implements corrective actions when necessary. • Represents the Clinical Affairs Department on cross-functional meetings and projects as needed.