Altasciences

• Conduct Privacy audits to determine current state and required actions (gap analysis) • Perform Privacy Impact Assessments as required • Assess and analyze privacy requirements, current state environment and technology platforms to define and propose solutions both administrative and technical to meet our Privacy obligations • Improve, and where needed, create our Privacy Program • Maintain the Privacy Register • Liaison with external Sponsor and Providers on Privacy matters • Maintain and update or create any required Privacy Policies and procedures • Conduct Privacy internal audits • Maintain a current knowledge of privacy laws and regulations • Work with IT to implement technical solutions (eg., Data loss Prevention, etc) • Work with the business to improve Privacy practices • Provide guidance to other departments (esp. Marketing) on privacy obligations and regulations

• Follow department and company standard operating procedures (SOPs), forms, templates and policies. • Provide feedback and update these guidelines as needed. • Act as the primary Data Management contact for the client and project team, proactively managing sponsor and interdepartmental expectations. • Develop strong client relationships that are driven by consistent study delivery in terms of quality and timeliness. • Develop, review, and maintain all study Data Management documentation. • Coordinate with Database Developers to ensure effective database build and timely go-live to meet the needs of the project. • Ensure the clinical database adheres to Clinical Data Acquisition Standards Harmonization guidelines allowing for optimal SDTM dataset programming. • Suggest design for standard and non-standard data collection, identify any gaps in data collection, and challenge collection of unnecessary data. • Define electronic case report form (eCRF) and edit check specifications to support data collection and analysis required per protocol. • Take responsibility for and guide effective quality control (QC) review and user acceptance testing (UAT) of the clinical database prior to its release into production, including oversight of staff performing these tasks. • Delegate and collaborate with Data Managers on data management cleaning activities including listing review, issuing and closing queries, and external vendor data reconciliation per protocol, department and client standards, and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines within the timelines expected by the client and project team. • Ensure data are properly reviewed in accordance with the Data Management Plan (DMP) and department and sponsor guidelines and that cleaning is effective and timely. • Track eCRFs to ensure appropriate updates and that all missing or discrepant data are queried appropriately. • Monitor key study metrics and provide status reports to the sponsor and project team. • Maintain the Data Management documentation for the trial master file (TMF) according to department and Project Management processes. • Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager. • Provide input into improving the efficiency of data management tasks. • Lead and participate in intradepartmental or interdepartmental process and quality improvement initiatives. • Oversee direct reports as assigned. • Mentor and train other team members and/or develop training materials as needed.

• Oversees key strategic client relationships to ensure customer satisfaction • Coordinates client needs across Altasciences sites and service lines • Facilitates internal and external information sharing • Acts as a point of escalation • Maintains oversight of customer portfolios • Collaborates with Business Development and Executive Leadership team • Responsible for identification and tracking of informative KPI’s • Identifies and implements process improvement initiatives • Advocates for both the Sponsor and Altasciences • Supports internal and external engagement in the company-wide commitment to Tell Us OnceTM • Consolidates monthly metrics and status updates on key Sponsors • Collaborates with Quality Assurance to ensure compliance is maintained

• Provide expertise, strong leadership, and management. • Ensure that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable Standard Operating Procedures (SOPs), regulations, Good Clinical Practice, and study-specific requirements. • Review visit reports and manage any issues brought to their attention by CRA staff and/or the study team and/or Sponsor. • Oversee Corrective Actions/ Preventive Actions (CAPAs) of assigned staff to ensure timely and sufficient resolution. • Track clinical monitoring metrics such as number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings. • May conduct monitoring visits to offer support to project teams. • Participate in the preparation, conduct and resolution of audits and inspections. • Contribute to the development, revision, and implementation of Clinical Monitoring SOPs, processes, and study tools. • Serve as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved. • Identify and implement professional development and performance evaluations. • Act as a mentor to team members to ensure growth and career development. • Ensure projects/studies are resourced appropriately by allocating and/or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of assigned staff. • Conduct Monitoring Oversight Visits to ensure compliance of clinical monitoring team members with regulations, SOP’s, and study requirements. • Prepare and review budgets for RFPs, as assigned. • Participate in Bid Defense Meetings, as assigned. • Perform ongoing reconciliation of clinical monitoring activities against budget. • Perform additional duties assigned by Clinical Monitoring leadership.

• Lead a team of Data Managers and Database Developers responsible for designing early phase clinical study data acquisition tools. • Review study data and deliver high quality Data Management outputs. • Oversee the planning and coordination of Data Management support across assigned studies and programs. • Drive innovation and continuous improvement in Data Management processes. • Proactively identify opportunities to modernize Data Management processes, evaluate emerging technologies, and implement enhancements. • Champion initiatives such as automation, workflow optimization, data visualization, and advanced data acquisition solutions. • Recruit, develop, and retain staff, and partner cross-functionally to meet departmental quality, operational, and financial goals. • Promote clear communication, strong collaboration, and a culture where new ideas and process improvements are encouraged.

• Provide day-to-day support for Workday Financials and Adaptive Planning end users. • Troubleshoot system issues and drive timely resolution. • Partner with Finance stakeholders to identify opportunities for automation, process improvement, and optimization. • Maintain system configurations to ensure data integrity and compliance with internal controls. • Gather business requirements and translate them into actionable system configurations. • Configure and maintain Workday Financials, including Financial Accounting, Accounts Payable (AP), Accounts Receivable (AR), Procurement, Banking & Settlements, Projects & Project Billing, Inventory, Intercompany setup and maintenance, Customer Contracts & Customer Invoicing. • Configure and maintain: Account Posting Rules, Allocations, Business Process Framework (setup and maintenance). • Develop and maintain custom reports (Advanced, Matrix, and Composite) and Worksheets. • Support Adaptive Planning administration and ongoing model enhancements. • Lead testing efforts for larger enhancement projects. • Coordinate and execute regression testing for bi-annual Workday releases. • Develop and maintain testing documentation and test scripts. • Partner with cross-functional stakeholders to validate business processes. • Plan, execute, and deploy system improvements and enhancements. • Support full project lifecycle activities including requirements gathering, configuration, testing, documentation, deployment, and post-go-live support. • Collaborate with internal stakeholders and external partners as needed. • Maintain documentation for system configurations and business processes. • Ensure proper change management and adherence to governance standards.

• Scheduling all Protocol-required tasks for in-life studies • Managing the department level study schedule and resources • Supporting Research Associate Supervisors, Study Supervisors, and Study Directors in scheduling • Creating the employee daily task schedule based on study schedule and departmental needs • Liaising with other departments to coordinate logistical challenges • Assisting with verification and posting of all generated schedules • Troubleshooting logistical challenges associated with workload and study execution • Maintaining consultant and contractor calendar as needed • Assisting in special projects as needed

• Provide expertise, strong leadership, and management. • Ensure that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable Standard Operating Procedures (SOPs), regulations, Good Clinical Practice, and study-specific requirements. • Review visit reports and manage any issues brought to their attention by CRA staff and/or the study team and/or Sponsor. • Oversee Corrective Actions/ Preventive Actions (CAPAs) of assigned staff to ensure timely and sufficient resolution. • Track clinical monitoring metrics such as number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required training. • May conduct monitoring visits to offer support to project teams. • Participate in the preparation, conduct and resolution of audits and inspections. • Contribute to the development, revision, and implementation of Clinical Monitoring SOPs, processes, and study tools. • Serve as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved. • Identify and implement professional development and performance evaluations. • Act as a mentor to team members to ensure growth and career development. • Ensure projects/studies are resourced appropriately by allocating and/or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of assigned staff. • Conduct Monitoring Oversight Visits to ensure compliance of clinical monitoring team members with regulations, SOP’s, and study requirements. • Prepare and review budgets for RFPs, as assigned. • Participate in Bid Defense Meetings, as assigned. • Perform ongoing reconciliation of clinical monitoring activities against budget. • Perform additional duties assigned by Clinical Monitoring leadership.