The position is a technical leadership position, accountable for the definition, oversight, and operational execution of Data Management (DM) deliverables for the Quantitative Sciences and Evidence Generation (QSEG) eCOA/eSource Team. This may include clinical study and program level deliverables for eCOA, and for eSource capabilities, such as wearables, Electronic Health Records (EHRs), applications (apps), eConsent, etc.

The role is responsible to provide operational leadership for eCOA and eSource deliverables, and to lead process oversight for clinical study and program level implementation. This includes responsibility for project management and technical leadership for the end-to-end study phases of setup, conduct, and closeout. This role drives operational excellence, global regulatory compliance, training and technology vendor process oversight for all DHT study level solutions and activities.

- Execution of eCOA and eSource process capabilities at a study, program, and enterprise level. This may include oversight and process ownership for the following: vendor deliverables and timelines, defining data collection, reporting and mapping requirements, establishing study level dataflow, technology/app and device deployment, testing, dataflow and data change oversight and archival activities.
- Establishes process for cross-functional coordination for eCOA/eSource implementation in collaboration with study teams, eCOA/eSource service provider(s), translations providers, and COA Specialist.
- Organize eCOA/eSource related meetings with vendors and study teams in accordance with Astellas processes




- Oversight of risk assessments and mitigation strategies to ensure on-time delivery of eCOA and eSource capabilities
- Provides operational process oversight for eCOA/eSource vendors (Has a broad understanding of how source data come together, and/or how system vendors and solutions function to support the execution of the study)
- Has a comprehensive understanding and application of eSource principles and regulations and represents data standards, quality, and inspection readiness interests with key stakeholders and study teams.
- Ensures adherence with best practices, operational playbooks, guidance documents, SOPs, work practice documents, tools, databases, and standard templates for eCOA and eSource.
- Responsible for ensuring that all supporting operational documentation for studies/systems is maintained in accordance with processes to ensure quality, traceability, and regulatory compliance.
- Leads process improvement activities that support operational efficiencies.
- Provides feedback and recommendations for operational governance discussions with key eCOA and eSource technology vendors.
- Maintains a strong network of contacts both within and outside of Astellas to further develop breadth and depth of knowledge.



Stays abreast of industry developments. Plays a leadership role in industry or professional organizations. Develops and maintains relationships with peers in the industry.

Qualifications
- BS in Computer Science, Informatics, or life science discipline; demonstrated previous experience in pharma or CRO industry in either an eCOA or relevant Data Management role.
- Seasoned expert with eCOA implementation and experience with eSource solutions implementation (wearables, eConsent, videography, EHR to EDC etc.)
- Demonstrated knowledge of the Clinical Development Process
- Demonstrated mastery of relevant DM skills (e.g., defining data collection requirements, applying data integrity principles, database design, dataflow etc.) in multiple drug development programs, inclusive of all activities from program inception to regulatory submission.
- Demonstrated active contribution to inspections and major (vendor) audits.
- Expert knowledge of local and international regulations for clinical trials (e.g., GCP).
- Advanced understanding of data management processes
- Expert level understanding of data integrity principles and other associated industry and regulatory level best practices and requirements
- Excellent verbal and written communication skills.
- Demonstrated learning agility, ability to rapidly adopt current technologies for Data Management
- Proven ability to work with and influence individuals across multiple disciplines and organizational levels in international environment.

📌 Digital Health Solutions Lead (Karnataka)
🏢 Astellas Pharma
📍 Karnataka