• Oversee staff performing TMF-related activities which may include document quality review and processing, TMF quality review, and/or study-level engagement to ensure filing of essential clinical study documents • Perform review of the study TMF Plan and TMF Document Index to ensure alignment of staff activities with study-specific requirements • Assist with addressing any cross-functional questions related to TMF management and alignment with study-specific documentation • Ensure proper execution of role-specific activities and oversee the quality of TMF support provided by Documents Specialists, Quality Review Specialists and/or TMF Leads • Complete periodic and random quality and completeness checks of work performed by team members • Review TMF metrics via system reports and dashboards and identifies process and staff performance challenges • Ensure any TMF-related documentation is filed in the eTMF when required • Identify systemic issues with quality and completeness of study-specific TMFs, recommend solutions and support team members in implementation of mitigation strategies • Support staff in communications with project teams related to issues and noncompliance with TMF-related standards • Work with staff to proactively anticipate challenges to TMF compliance and identify early signals of risk • Develop and implement plans to increase compliance and follows-up on non-compliance • Support audits and inspections and attend audit/inspection meetings when needed • Address escalations related to TMF issues and lead implementation of solutions and mitigation strategies • Support team members on internal and external study calls if issues and escalations emerge • Support Business Development activities, such as Proposal responses or participation at Bid Defense meetings related to TMF processes • Monitor team member assignments on studies in line with budgets and oversee the reporting of potential out of scope activities to PM, as needed • Oversee staff performing job responsibilities in Sponsor eTMF Systems and actively listen to deliver insightful solutions for challenges faced by team members • Engage with cross-functional stakeholders and Sponsors to eliminate emerging issues with completeness or quality

• Oversee staff performing TMF-related activities which may include document quality review and processing, TMF quality review, and/or study-level engagement to ensure filing of essential clinical study documents • Perform review of the study TMF Plan and TMF Document Index to ensure alignment of staff activities with study-specific requirements • Assist with addressing any cross-functional questions related to TMF management and alignment with study-specific documentation • Ensure proper execution of role-specific activities and oversee the quality of TMF support provided by Documents Specialists, Quality Review Specialists and/or TMF Leads • Complete periodic and random quality and completeness checks of work performed by team members.

• Gesamtverantwortung für die Steuerung und Koordination von Einführungsprojekten unserer Business Intelligence-Lösung beim Kunden • Enge Abstimmung mit den Kunden zur Sicherstellung der kundenorientierten Umsetzung der Projekte • Verantwortung für Budget, Termine, Erfolg und vertragskonforme Umsetzung der Projekte • Koordination und Steuerung der Projektteams und Verantwortung für das Coaching der Projektmitarbeiter • Dokumentation des Projektverlaufes sowie der Ergebnisse und Erstellen kundenspezifischer Umsetzungskonzepte

• Manages end-to-end product and engineering delivery • Ensures alignment to business objectives, measurable outcomes, and client needs across multiple concurrent initiatives • Leads the evolution of product management and engineering best practices • Oversees the enhancement, design, pricing, and lifecycle management of products and services • Drives secure development practices across the lifecycle • Identifies opportunities to leverage AI/ML and Generative AI to improve engineering productivity • Maintains revenue forecasts and identifies risks to financial targets