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 16,000 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 Manager, Clinical Database Application and Reporting is a member of the Biostatistics and Data Management Data Operations team and serves as a subject matter expert responsible for the analysis, implementation, support, and maintenance of clinical database applications and reporting. This position reports to the Associate Director/Director, Data Infrastructure Operations. The responsibilities include business process and analysis of new and/or existing applications, technology, and infrastructure; coordination, testing, authoring, and maintaining documentation including requirements, use cases, test scripts, end-user job aids & work procedures; authoring business continuity plans and system SOP/SOIs; maintaining compliance and inspection readiness with systems and supporting processes documentation; and extending operational systems support for Electronic Data Capture (EDC), and Clinical Data Repository (CDR) systems, among others. This position will collaborate with members of Biostatistics and Data Management, Clinical Study teams, IT Service Management, QA, external partners, and other stakeholders.
Leadership, Direction, and Strategy:
- Establish, coordinate, and manage business process and analysis of new and/or existing production clinical database applications and reporting including authoring and/or reviewing of functional requirements, testing, deployment planning, process documentation, GxP compliance and inspection readiness, and ongoing operational improvements.
- Provide end-user business process, testing, technical support, and guidance in the use of EDC and CDR for Data Management and clinical study teams.
- Manage the coordination of the Data Operations clinical database applications and reporting activities with the various stakeholder groups including the BDM infrastructure committees, Data management, external partners, Information Services, Quality, and Technology partners.
- Lead and manage end-to-end testing strategy, including authoring, reviewing, and/or facilitating the execution oversight of comprehensive unit, and functional test scripts for the business system in preparation of user acceptance and production use.
- Manage the planning, coordination, and testing pertaining to EDC and CDR post-production changes, system patches and upgrades.
- Develop custom programming and reporting specifications and manage quality expectations in partnership with internal and external stakeholders, as needed.
- Ensure effective quality oversight of the core Data Management systems, supporting processes and infrastructure; maintain audit and inspection readiness of all deliverables and documents.
- Proactively identify and resolve issues that may influence and/or impact study quality and other deliverables.
- Serve as a subject matter expert for the analysis, implementation, support, and maintenance of clinical database applications and reporting for use by the clinical study teams.
- Develop, manage, and maintain business process and applications-oriented job aids, work procedures, and SOP/SOIs for improved consistency in use, compliance, and quality.
- Contribute to the development and maintenance of business contingency plans for the core clinical database applications used by Data Management in partnership with study data managers, technology vendors, EDC Delivery Services, and CDR operational support teams.
- Provide operational technical support and guidance in the planning, setup, and application of security and access models for clinical data in EDC and CDR.
- Provide peer review support for EDC study database build activities, including review of eCRF Requirements, edit check specifications, data listings and reporting specifications for the study in partnership with the EDC delivery services team.
- Partner with the EDC and CDR business system administrators to facilitate in the periodic review of the user access management reports for internal and external users of the systems to maintain compliance and inspection readiness.
- Support end users in the resolution of application issues, challenges with workflows, and orchestrate modifications and/or enhancements to serve expanded use and/or new purposes.
- Achieve standardization of guidance documents, forms, logs, templates, and milestone trackers to maximize productivity, improve compliance, and efficiencies.
- Engage and contribute to business process improvements, workflow efficiencies, productivity, and quality improvements initiatives.
- Support preparations and follow-up actions related to internal audits and health authority inspections.
- Assist in the improvements of data standards and strategies pertaining to the global standards library.
Operational Efficiency / Continuous Improvement:
- Identify opportunities for continuous process, technology, workflow, and operational improvements.
- Identify and engage in process automation initiatives for improved efficiencies, quality, and productivity.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's Degree or higher in life sciences or related field is required
- Minimum of 5 years of Global Clinical Trial Experience in the device/pharmaceutical/CRO industry with expertise in Electronic Data Capture, Clinical Data Repository, and Reporting systems is required.
- Knowledge of clinical programming, methods, and techniques; knowledge of unit and functional testing of application is required
- Knowledge and understanding of relational databases; compliance and CAPA response & management is required
- Knowledge of CDASH and CDISC data standards is required
- Knowledge and understanding of data acquisition and integration tools and technologies is required
- Collaborate with people at various levels of experience, different disciplines, and cultures.
- Self-directed; able to work independently and manage multiple priorities.
- Effective communication, negotiation, and conflict resolution skills.
- Knowledge and experience in maintaining systems, processes, and quality deliverables for inspection readiness.
- Knowledge of industry leading EDC technology platforms (Medidata RAVE, Veeva CDMS, Oracle Inform, Merative, etc.).
- Knowledge of Clinical Data Repository and Reporting tools (SAS, JReview, Business Objects, Spotfire).
- Knowledge of application testing methods, techniques, and best practices and technical writing skills.
- Knowledge of drug development, computer systems validation, regulatory compliance, and 21 CFR-Part 11.
- Proficient in industry standards, medical terminology, and clinical trial methodologies.
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.