Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Associate Director, EDC Business Process and Workflow Management, will be a member of the Biostatistics and Data Management team and provide leadership, oversight, and guidance for all EDC business processes and other related workflow management activities. This position will manage EDC processes, system workflow activities, and deliverables to support internal, cross-functional, and external business requirements in conformance with applicable GxP requirements, global regulations, data security, data privacy and data protection guidelines. To that end, the individual will provide subject matter expertise, technical support, and guidance with commitment to compliance, quality, and standards. The individual will lead and deliver enhanced capabilities and innovative solutions that enable future proof study execution and workflows. In addition, the individual will also engage in EDC administrative and operational improvements including optimization of core configurations, capabilities, and system behaviors. This position will work closely with other members of the Biostatistics and Data Management, R&D Excellence, external CRO partners, functional service providers, and other stakeholders.
Responsibilities
Leadership, Direction, and Strategy:
- Provides leadership, oversight, and guidance for EDC business processes, and other related EDC components, workflow activities, and deliverables.
- Manages strategic input into data flow for EDC and external data based on the study requirements.
- Establishes EDC workflow standards, integration business requirements, and data integration/exchange agreements at the program and study level.
- Leads and deliver new capabilities, operational improvements, and innovative technical solutions that enable future proof study execution and workflows.
- Ensures all EDC business processes, system integrations, and deliverables are consistent with applicable regulatory and business requirements.
- Proactively identifies and mitigates EDC system and workflow risks in collaboration with internal and external stakeholders.
- Manages direct reports and contract staff.
Project Management:
- Plans and directs the EDC business processes, EDC components, configuration, and workflow activities for all outsourced and internally conducted clinical studies.
- Coordinates with study builders, study data managers, functional service provider(s), and cross-functional teams on the workflow touchpoints between EDC and other peripheral systems relevant for each study
- Manages and maintains all EDC integration design specifications and deliverables for all outsourced and internally conducted clinical studies.
- Manages timelines, identifies critical activities and risks proactively, develops and implements mitigation plans, and provides status reports.
- Engages with external CROs on EDC system integration business requirements, ensures timely review and sign-off, and delivery of the data integration/exchange agreements.
- Manages and maintains deliverables pertaining to the operational use of the EDC platform and its components, post-production changes, process improvements, EDC administration, migration planning, and impact assessment.
Functional Expertise:
- Expertise in Clinical systems and Platforms (e.g., iMedidata Product suite – RAVE, Lab Administration Module, Coder, TSDV, RAVE Safety Gateway, Medical Imaging etc.), Clinical Trial Management System (CTMS), Clinical Sample Management System (CSM), Randomization and Trial Supply Management (RTSM), eConsent, Third-party adjudication tools, Data Lake, and Data Review tools.
- Provides guidance on EDC core configurations, capabilities, and system workflow behaviors.
- Shapes the EDC System Integration Strategy in partnership with internal, cross-functional, and external stakeholders.
- Reviews the assessment of critical data points required for system integrations; confirms applicable data point restrictions for implementation in conformance with the required program and study level blinding guidance and relevant business rules.
- Ensures that the EDC system integration(s) conforms to applicable GxP requirements, global regulations, data security, data privacy and data protection guidelines.
- Reviews and provides feedback on the EDC system integration strategy, opportunities for optimization of integration services, and recommendation for production use.
- Leads the functional and user acceptance testing deliverables of interfaces between EDC system and other peripheral systems including RTSM, eConsent, CTMS, CSM, and Data Lake.
- Provides oversight, technical support, and guidance to the study teams in the efficient use of the iMedidata product suite for study planning, conduct, close-out and decommissioning of clinical studies.
- Provides oversight on post-production changes, including proactive assessment and mitigation of risks in collaboration with external partners and/or functional service providers.
- Provides oversight on the management of all local lab activities in EDC including conformance with correct analytes, units, conversion factors, and definition of textbook ranges.
- Guides the implementation of the RAVE Safety Gateway with the Safety System for all studies in partnership with the study builders, study data managers, safety team, and Medidata.
- Participates in QA vendor audits and engages on resolving CAPA related activities pertaining to EDC.
Operational Efficiency / Continuous Improvement:
- Provides EDC process and operational leadership within Data Management by partnering with internal and external stakeholders to optimize and deliver integrated and streamlined workflows for study execution across different systems.
- Leads EDC operational improvement initiatives; explores opportunities to minimize complexities and interdependencies; leads efforts to identify future system capabilities and enhancement opportunities.
- Leverages industry standards and best practices; embraces lean integration to improve efficiencies and maximize value through continuous improvement and automation.
- Ensures continuous improvement of processes, tools, and outputs to be used to facilitate advancement of project portfolio.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Master's Degree in life sciences or related field preferred
- Bachelor's Degree in life sciences or related field preferred
Experience Qualifications
- 7 or More Years of Clinical Systems and Support including EDC, CTMS, RTSM, CSM, and other peripheral systems in the device/pharmaceutical/CRO industry; expertise in the iMedidata suite or products, Veeva CDMS or equivalent; expertise in Tableau, Spotfire, JReview and other reporting and data visualization tools; expertise in the review and use of RAVE Web Services, REST APIs, and raw data extraction techniques. Required.
- 4 or More Years combined experience managing complex workflows; experience overseeing the linking of cross-functional applications between different GxP systems and vendors providing data integration services. Preferred.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
