• 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