Senior Manager (m/f/x) ePRO/eCOA Data Management

Job Title: Senior Manager (m/f/x) ePRO/eCOA Data ManagementPosting Start Date: 21/11/2025Job Description:We are seeking a highly qualified candidate to fill the position:Senior Manager (m/f/x) ePRO/eCOA Data Management The Position:The Senior Manager, ePRO/eCOA (electronic Patient Reported Outcomes / electronic Clinical Outcome Assessment ) at Daiichi Sankyo R&D oversees the end-to-end delivery of Patient Reported Outcomes, collaborating with cross-functional teams and external vendors to support drug development and global submissions. This role provides data management expertise, ensuring high-quality ePRO/eCOA data delivery, optimizing data collection, and proposing strategies aligned with protocol-defined analysis endpoints. Additionally, the position supports clinical teams in implementation, requires knowledge of industry standards and data integration, and demands strong communication, project management, and risk management skills in a fast-paced environment.Roles and ResponsibilitiesLead implementation of ePRO/eCOA strategies, ensuring consistent data acquisition, processing, and integration across programs while engaging vendors and cross-functional teams.Develop, maintain, and author key procedural documents (SOPs) and data templates to standardize ePRO/eCOA data across Daiichi Sankyo.Serve as subject matter expert supporting data management staff and study teams throughout ePRO/eCOA data lifecycle, including complex data collection deliverables.Oversee vendor engagements, contracts, and service agreements to establish data standards, cleaning requirements, and quality delivery.Manage planning, supervision, and approval of User Acceptance Testing (UAT) activities for eCOA implementations and post-production updates.Ensure compliance with protocols, SOPs, GCP, regulatory requirements, and internal policies across outsourced and in-house ePRO/eCOA data management activities.Collaborate with Study Data Managers and vendors to oversee system setups, device configurations, and proactively manage vendor-related risks and issues.Lead design, delivery, and integration of clinical systems related to ePRO/eCOA; participate in technology selection and vendor evaluations including RFPs and change orders.Promote continuous improvement by leading knowledge sharing, training, and process documentation while optimizing vendor data exchange processes.Stay updated on data trends, regulatory changes, and technology innovations to enhance Daiichi Sankyo’s ePRO/eCOA data processes and standards governance.Personal Skills And Professional Experience:Extensive experience with successful implementation of ePRO/eCOA systems (required).Bachelor’s Degree or higher in life sciences or related field (required).Strong knowledge of good clinical practices (GCP), data standards, and regulatory guidance related to PRO and eCOA (required).Deep understanding of Patient Reported Outcomes (PROs) and common eCOA systems (required).Experience implementing clinical systems such as CTMS, EDC, and ePRO (required).Clinical data management experience in pharmaceutical, medical device, CRO, or related environments, preferably in oncology, immunology, or complex diseases (required).Working knowledge of clinical trial data systems and/or EDC management tools is a plus.Intense knowledege of combined experience managing people and initiatives, including vendor oversight for data management services (required).