Manager Real-World Data

📋 Description

• • Lead and manage the Real-World Data (RWD) team, including RWD Associates, Specialists, and Interns, ensuring clear role definition, performance tracking, and professional development.
• • Develop and maintain the overarching RWD collection strategy for myTomorrows, aligning with organizational goals and regulatory expectations across global operations.
• • Oversee the design, implementation, and execution of RWD collection within Expanded Access Programs (EAPs) and non-interventional studies, ensuring data integrity and adherence to protocol specifications.
• • Support BioPharma clients on electronic Case Report Form (eCRF) design, database architecture, and data management planning to optimize RWD capture and usability.
• • Author, review, and update RWD-related policies and Standard Operating Procedures (SOPs) within myTomorrows’ Quality Management System to ensure compliance with international standards.
• • Represent myTomorrows as the primary external voice on RWD topics at industry conferences, client meetings, regulatory audits, and partnership discussions.
• • Build and sustain internal awareness and understanding of Real-World Data across departments, enabling cross-functional alignment on data usage, limitations, and opportunities.
• • Stay current with evolving regulatory frameworks, data collection methodologies, and industry best practices specific to EAPs and non-interventional real-world evidence generation.
• • Collaborate with clinical, compliance, and technology teams to integrate RWD workflows into the company’s AI-powered platform, enhancing automation and data scalability.
• • Ensure all RWD activities meet ICH-GCP guidelines and local regulatory requirements across 134 countries where myTomorrows operates.
• • Drive continuous improvement of RWD data quality metrics, reducing errors and enhancing the reliability of datasets delivered to BioPharma clients.
• • Contribute to business development initiatives by articulating the value proposition of myTomorrows’ RWD capabilities to prospective clients and partners.
• • Monitor project timelines and deliverables for RWD programs, ensuring consistent, high-quality outputs aligned with client expectations and contractual obligations.
• • Act as the internal subject matter expert on RWD, responding to inquiries, resolving ambiguities, and providing guidance to internal teams and external stakeholders.
• • Foster a culture of compliance, accountability, and data excellence within the RWD team and across client-facing projects.
• • Participate in client onboarding and training sessions to ensure smooth adoption of myTomorrows’ RWD protocols and data submission requirements.
• • Evaluate emerging technologies and tools that can enhance RWD collection efficiency, accuracy, and regulatory readiness.
• • Maintain documentation for audit trails and inspections, ensuring readiness for sponsor, regulatory, or third-party audits related to RWD activities.
• • Proactively identify risks in RWD processes and implement mitigation strategies to safeguard data integrity and client trust.
• • Work closely with the Data Science and Technology teams to translate RWD insights into actionable inputs for platform improvements and client reporting.