Rho

• Manage the end-to-end clinical execution of projects up to moderate complexity and scope and/or supports a senior-level CTL on more complex or larger scope projects, ensuring adherence to protocols, timelines, and regulatory requirements • Oversee recruitment, study metrics monitoring, and documentation activities. With guidance, identify issues and contribute to implementing solutions • Ensure sites comply with Good Clinical Practice (GCP) and applicable regulations • Collaborate with cross-functional teams (e.g., data management, regulatory, safety) to facilitate study deliverables • Develop and manage clinical operation timelines, metrics, resourcing, budget and activities of projects up to moderate complexity and scope. May also support senior CTLs on more complex or larger scope projects • Identify potential risks and escalate to appropriate stakeholders, supporting collaboration and leading implementation of appropriate corrective actions and mitigation strategies • Manage tracking and reconciliation of clinical budgets related to clinical operation activities such as monitoring visit and CRA allocation. Identify potential budget variances and escalate to appropriate stakeholders to ensure timely corrective actions are taken and cost-effectiveness is maintained • May assist with RFP strategic planning, budget development, and capabilities/response narratives • Perform monthly assessment of CRA resourcing projections based on study parameters (e.g., active sites, projected Days On Site, upcoming milestones, etc.). Work with CRA Line Management to proactively confirm resourcing needs • Serve as the lead clinical liaison among Clients, site staff, and internal teams on projects up to moderate complexity • Lead internal and external meetings • Manage routine Client communications and help manage client expectations • Communicate and work effectively with site staff, as needed, serving as an escalation point for CRAs as issues arise • Lead CRAs and IHCRAs, including project training and onboarding. • Create and conduct training sessions including investigator meetings, conferences, and team training • Provide constructive performance feedback on CRAs/IHCRAs to line managers and project leads • May participate in Bid Defense Meetings to present clinical operation and monitoring strategy • Participate in upfront Protocol Deviation planning and identification, in support of finalization and maintenance of Protocol Deviation Plan and related activities • Manage protocol deviation review and reconciliation throughout the study, ensuring timely documentation and resolution in collaboration with cross-functional teams and Client for review and approval on projects of up to moderate complexity • Support the identification and continuous assessment of clinical risks throughout the study and contribute to the development and implementation of risk mitigations on projects of up to moderate complexity • Provide skilled review and development of study protocols and study-related documents and materials (e.g., clinical monitoring plan, protocol deviation plan, case report forms) • Oversee and perform on-site Quality Compliance Visits to review data across CRAs using a targeted, adaptive and/or risk-based approach focused on critical and safety related data points. Identify trends and potential quality issues, escalating as appropriate. Collaborate with CRAs and study teams to implement corrective and preventive actions

• Define and continuously evolve Rho’s patient recruitment strategy framework, standards, tools, and decision-making models used across all clinical programs. Works closely with the Feasibility leadership on developing long-term capability roadmap, • Leverage sponsor-provided materials, develop trial-, country-, and site-level recruitment strategies based on protocol design, feasibility strategy, targeted patient population, competitive landscape, and operational considerations • Translate feasibility insights into actionable recruitment plans, including tactical mix recommendations (digital, community-based, site support, etc.) • Serve as the strategic recruitment lead on select trials during study start-up and enrollment, advising on risk mitigation and optimization opportunities as well as driving strategic pivots when necessary • Ensure recruitment strategies are data-driven, scalable, and aligned with Rho’s operational structure • Advise Rho’s Clinical Management team on site- and study-level recruitment plans, equipping the members of this team with the necessary insights and site-level messaging to facilitate plan execution • Develop tailored recruitment approaches that align with Rho’s Core 4 therapeutic areas: neuroscience (psychiatry and neurology), respiratory, pain (acute and chronic), and immunology (inclusive of dermatology) • Partner with Business Development, Feasibility and Clinical Management teams to support RFPs and proposal development, including: • Compose recruitment approach narratives in Rho proposals • Augment and complement feasibility benchmarking, integrating the impact of recruitment strategy into enrollment assumptions and timelines • Advise on securing vendor bids, align recruitment strategies with vendor representatives, and provide cost considerations on recruitment services • Contribute to sponsor-facing discussions by articulating clear, defensible recruitment strategies grounded in evidence and experience • Support bid defense meetings as a subject matter expert in patient recruitment strategy, as necessary • Lead and support vendor prioritization, selection, and onboarding for external recruitment services (e.g., digital campaigns, physical materials, outreach vendors, site-level recruitment tools and technology) • Define vendor performance expectations, success metrics, and governance models in collaboration with study teams • Monitor vendor performance using recruitment KPIs and analytics, escalating risks and recommending corrective actions as needed • Act as a strategic liaison between internal teams and external vendors to ensure alignment with study goals and recruitment budgets • Create and maintain a library of vendor experience and performance profiles based upon Rho studies and core therapeutic areas • Oversee and interpret recruitment data and performance analytics, including enrollment trends and site-level indicators • Leverage historical and real-time recruitment data, working with Rho study teams and sponsors to: • Optimize initially scoped study recruitment strategy • Identify enrollment risks • Provide recommendations for pivots in recruitment strategy to optimize recruitment spend • Inform future feasibility and proposal strategies • Translate complex data into actionable insights and recommendations for internal stakeholders and sponsors • Act as the recruitment subject matter expert for any required systems and technology integrations to optimally leverage recruitment metrics • Lead cross-functional alignment on recruitment strategy direction, partnering closely with Feasibility, Study Start-Up, Clinical Operations, and Project Management teams to ensure cohesive recruitment planning • Drive the development of standardized recruitment frameworks, tools, procedural documents and best practices for this new unit • Serve as an internal thought leader on patient recruitment innovation, trends, and emerging methodologies • Act as a trusted strategic advisor to sponsors, providing clear guidance on recruitment feasibility, risks, and trade-offs as it relates to tiered approaches of recruitment spend • Act as the primary escalation point and strategic advisor for complex, high-risk recruitment challenges across the organization. • Ensure alignment between recruitment strategy, business development, and operational execution at an organizational level

• Proactively drive project success, including working closely with cross-functional study leadership to develop and implement operational strategies. • Identify and mitigate clinical risks, as well as contribute to the development of the quality risk management plan. • Provide skilled review of study protocols and other study materials (e.g. CRF). • Develop and manage clinical operations timelines, metrics, resourcing, budget and activities. • Develop monitoring tools and plans. • Accountable for operational aspects of planning and oversight of site performance in accordance with departmental productivity expectations. • Create and conduct training sessions including investigator meetings, conferences, and team trainings. • Determine and drive the study start up process (track and report progress, review data), ensuring that all sites are selected and supplies provided in accordance with study expectations. • Provide status updates to project management and sponsors. • Lead regular clinical team teleconferences. • Work effectively with Site staff, as needed, serving as an escalation point for CRAs as issues arise. • Manage clinical Site communication and documentation of decisions, including mass correspondence to sites regarding study updates. • Participate in the RFP process, including internal and external business development meetings. • Review monitoring visit reports and ensure finalization is within contractual timeline. • May assist Project Managers with project management tasks as assigned. • Support the management and development of In-house CRAs and CRAs.

• Manage the study start up process through site activation, working with Project Manager and Clinical Trial Lead to ensure timely site activations • Participate in Sponsor meetings with respect to study start up, including endorsement of the SSU Operational Targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics • Partner closely with both Functional Leads and SSU Team Members to proactively identify study start up related issues • Ensure that relevant systems are maintained and up to date to analyze study start-up progress metrics against targets/timelines (at a project/country/site level) • Provide operational oversight to SSU Associates on assigned projects • Responsible for all submissions and obtaining approval from IRB/ECs (incl CTIS Part 2 package); • May be responsible for submissions to Regulatory Authorities in non-EU countries (ex. UK, Georgia, South Africa etc) • Coordinate feasibility efforts and work together with Clinical Team Leads on site identification • Identify the Site Essential Document (SED) packet elements required, agree with relevant internal staff, track the completion and upload of documents, and communicate with all parties (e.g., Sponsor, Site Staff, Internal Staff) the status of documents; participate as the SED Reviewer as necessary • Coordinate and develop the Start Up approach for IRB/EC approval at specified regional levels, including country level approval, and provide oversight of specific activities from SSU Team Members • Partner with Clinical Team Leads and the client to identify requirements for the Site Initiation Visit (SIV) and Site Activation • Coordinate the informed consent form (ICF) development, including the review, negotiation and approval with relevant internal and external parties • Support business development with proposal preparation and review and bid defense efforts • Coordinate site budget development, including the review, negotiation and approval with relevant internal and external parties. • Coordinate site contract negotiation process • Develop country/site-specific startup timelines and strategies and oversee startup activities in the country • Facilitate cooperation between cross-functional teams regarding startup activities

• Perform business analysis, validation, and testing processes to support software development in regulated clinical research • Direct validation testing to ensure final outcomes meet specified requirements • Ensure and facilitate corporate compliance with applicable regulations concerning software development and maintenance • Work closely with business primes to document requirements and business processes • Identify and schedule project deliverables, milestones, and tasks for software validation • Research, develop, and write validation content for software products and services • Prepare and maintain documentation relating to users, systems, programming, and validation • Create graphical images, flow charts, and diagrams for documentation • Develop and/or participate in SOPs to ensure regulatory compliance • Ensure adherence to SOPs, regulatory validation, and quality assurance plans • Act as an independent quality reviewer for peer software validations • Ensure developed application documents meet project and SOP requirements • Ensure compliance with testing environment requirements for validation testers • Create and/or execute acceptance tests for software under development or commercial products • Coordinate recruitment, training, and testing of qualified testers for acceptance testing

• Supports in preparation of ISFs (Investigator Site Files). • Contact, communication and guidance to CRA and sites as instructed by Trial manager • Maintenance of TMF (Trial Master File) or the CRO Project File and periodically review the TMF and/or CPF to ensure accuracy, completeness. • Upload Country and Site level documents in Veeva Vault in a timely manner. • Timely transfer of Study documents (scanned copies) to Sponsor, as agreed, on an ongoing basis. • Supports in preparation of documents package for submission to CA (Competent Authorities) and EC (Ethics Committee), and support for EU CTR submissions • Facilitate the communication between stakeholders in regards to documentation management • Provide support to stakeholders on the planning, collecting, filing, confirming, archiving of trial records, as needed • Support the stakeholders to confirm records availability at specific timepoints, as required by Sponsor procedures • Sponsor/ Rho team meetings preparation, drafting meeting minutes. • Maintains tracking information for Study activities. • Support Trial Manager on data entry and maintenance to systems (includes correction of wrong data entry) • Supports CRA (Clinical Research Associate) in maintaining ISF at Site. • Support sites getting access to systems, as needed • Support Trial Manager sharing updates with sites • Support on audits and/or inspections

• Process high volumes of supplier invoices across assigned entities and regions, in accordance with applicable local requirements and global AP processes • Handle and process T&E (Travel & Expense) claims in line with company policies • Ensure invoices are accurately coded and approved in line with company policies • Verify invoice details, including applicable tax treatment, invoice compliance, and documentation requirements based on the relevant jurisdiction • Manage supplier queries and resolve discrepancies promptly • Maintain accurate and up-to-date vendor records • Support payment runs, ensuring deadlines are met • Reconcile supplier statements and investigate outstanding items • Assist with month-end closing activities related to accounts payable • Collaborate with internal stakeholders across different countries and departments

• Leads the notebook tasks associated with project-specific reporting, working across the project team to ensure final reports meet the needs of all internal stakeholders. • Serves as technical support for Rave EDC build, including custom function programming. • Develops, validates, and makes updates as needed to a library of template notebooks to support reporting needs. • Programs data listings for Protocol Deviation review. • Capture, develop, and document data definitions, business rules, and data quality requirements. • Ensure compliance with deliverable reporting requirements by performing quality data audits and analysis. • Communicate and present data recommendations in a clear and compelling way. • Identify opportunities for data and process improvement, innovation, and optimization. • Participate in projects and tasks related to data integration, data cleaning, descriptive analyses, exploratory analyses, predictive modeling, data mining, text analytics, social media analytics, social network analysis, rapid prototyping, and data visualization to solve problems. • Implement new statistical or other mathematical methodologies as needed for specific models or analysis

• Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users • Use your expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design • Use study protocol, CRF, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implementation guides to independently author SDTM specifications from scratch; use Pinnacle 21 to run data conformance and create define.xml for SDTM and ADaM submissions • Act as the CDISC subject matter expert • Convert designs and specifications into computer code and analyze code to find causes of errors and revise programs • Write and maintain documentation of changes to computer code, programs, and specifications • Review user and technical documentation written by others to confirm consistency with program operations • Offer expertise relevant to statistical programming and CDASH data collection for study start up, execution, and close out: review protocols, draft CRFs; prepare and review validation plans, review vendor DTAs, etc • Modify and maintain software programs written by others • Provide mentorship and training to peers and more junior programmers in areas of expertise • Ensure effective, accurate and timely communication of key issues and progress to the team and Sr. Management • Perform functional lead activities on assigned projects while maintaining scope and budget oversight • May provide guidance and input to the budgets and business submissions of proposals

• Site administration and site monitoring responsibility for assigned clinical studies according to Dokumeds and Sponsor Standard Operating Procedures, legal requirements and ICH-GCP Guidelines • Conduct of country and site feasibility • Site initiation, routine monitoring and close-out visits • Preparation and submissions to Ethics Committees/Regulatory Authorities • Assistance in site contract management