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 Responsibilities

• Lead 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).