• Planning, executing, managing, and oversight of clinical studies and projects according to Research ethics guidelines, ISO standards, internal SOPs, and portfolio priorities • Serve as a cross-functional lead within an assigned study portfolio, ensuring alignment across Clinical Operations, Product Management, Data Management, Regulatory, Compliance, and other key stakeholders • Provide accurate, timely status reports and portfolio-level updates on assigned clinical research studies and projects • Facilitate appropriate documentation to maintain compliance with the AP and Compliance department for HCP transfers of value • Facilitate clinical contract agreements between Arthrex and the Site for studies • Assist the data management team with electronic data capture systems CRF design, eTMF design, CTMS design and user testing for assigned studies • Provide centralized communication and coordination between research sites and internal cross-functional stakeholders • Facilitate site training for data collection clinical research initiatives • Monitor data collection compliance and communicate with sites to optimize data collection • Provide the main line of communication with research sites • Facilitate IRB approval at the site and sponsor level • Oversee and approve site activation activities for studies, ensuring readiness across all functional areas • Collaborate on reviewing protocols, case report forms, and informed consent for clinical studies • Qualify sites for participation in assigned studies • Complete central, remote, and on-site monitoring visits, reports, and follow-up letters • Identify study- and portfolio-level risks or issues, implement mitigation strategies, and develop CAPA plans as appropriate • Works closely with the other clinical research professionals and cross-functional partners to ensure successful study execution • Conduct regular investigator meetings to ensure protocol compliance and site engagement • Actively participate in research committees, study groups, and cross-functional portfolio governance activities to support continuous improvement and strategic alignment • Engage in and support departmental initiatives and cross-functional team projects, collaborating by driving execution, problem-solving, and achievement of key business outcomes

Support operational management of study activities, assist in study implementation, ensure compliance with protocols, and maintain effective relationships with community partners while engaging with families and children for recruitment and data...

• Manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes • Leads RBM strategy meetings and develops study-specific site monitoring plan, aligned with study risk assessment • Ensures monitoring strategies are configured in technology capabilities • Manages Site Monitoring assignments in client's systems • Provides Site Monitoring training and supports the creation and delivery of site monitoring materials • Serves as primary reviewer of site monitoring visit reports • Reviews systems and dashboards to assess site monitoring compliance • Supports site monitoring needs during study conduct • Provides site management back-up as needed while Site Monitors are conducting site monitoring visits • Triggers and manages or conducts Monitoring Oversight Visits • Partners with RBQM Operations team to address unresolving centralized monitoring findings with sites • Performs periodic assessment of site monitoring / RBM compliance KPIs and KQIs

• Design and conduct clinical studies that evaluate the safety and efficacy of innovative treatments. • Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations. • Contribute to the identification, formulation and implementation of amendments to the clinical protocol, in close collaboration with clinical lead. • Contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. • Contribute to the review and writing of clinical trial documents for CTR activities, and publications (as applicable) • Support pharmacovigilance activities (e.g. contributing to creation and review of aggregate reports, patient narratives and attendance of pharmacovigilance monitoring meetings) • Support regulatory activities (preparation of meetings with regulatory agencies). • Produce training materials, share best practices and provide training to the broader clinical trial teams. • Support preparation and (if applicable) participate in study level meetings (i.e. - Investigator Meetings, Data Monitoring meetings, and others). • Support and guide the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites). • Include support for Case Report Form (CRF) development, and implementation of data capture tools. • Deep expertise to perform in depth and high-quality clinical data review, to identify clinical data insights through ongoing patient level review and trends analysis to support Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle. • Work to improve the quality of reviews and insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review. • Provide insights to and facilitate data review process improvements by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement.