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.
The Manager, Clinical Data Repository Administration is a member of the Biostatistics and Data Management Data Operations team and serves both as a subject matter expert and leader of a group responsible for the business administration of the CDR/AP system(s) including the areas of study setup, creation and maintenance of standard hierarchy structures and user access controls for all clinical studies. This position may have direct reports and/or dedicated external resources and will have responsibility for training, mentoring, work assignment and oversight of the group.
This position reports to the Associate Director, Data Management Operations. Business administration activities within the CDR system may include the Creation & maintenance of standardized and custom user roles and data hierarchies, assignment of users to roles based on authorized requests from study team members, periodic review of user access and audit trail reconciliation, impact analysis and documentation of identified access discrepancies per study to maintain overall compliance and inspection readiness of the application. This position will establish and maintain traceability of data access requests, procedures for the periodic review, and process improvements. This position will also work with members of Data Operations, DM, and Biostatistics, Clinical Study teams, IT/Information Services and other stakeholders on developing and maintaining new SOPs, Work instructions, templates, and other quality documents.
Leadership, Direction, and Strategy:
- Establish and manage accountability for the accuracy and integrity of all User Access and coordinate the timely processing of requests and delivery of periodic review reconciliation reports
- Manage all quality deliverables for the timely processing of access requests in accordance with our GSOP/GSOI and maintain inspection readiness of the documents in partnership with the study data managers.
- Ensure effective quality oversight on the requests submitted by DM and authorized study team members.
- Proactively identify and resolve issues that may influence and/or impact study quality and other deliverables.
- Work closely with the study teams to develop custom access specifications, support adhoc data reporting needs, and manage quality expectations in partnership with internal and external stakeholders, as needed.
- Partner with the study data managers to facilitate in the periodic review and acceptance of the study user and role assignments in the Clinical Data Repository.
- Serve as a subject matter expert and provide oversight and technical support in the planning, setup, and application of security and access models for clinical data in CDR.
- Contribute to designing and planning the foundational capabilities for the new CDR versions/system being implemented including establishing folder hierarchies, security matrices and role definitions.
- Improve the review and coordination of periodic review of user access with the business and our partners for end-to-end improved quality, consistency, security and integrity for all studies. - Establish log/traceability of data access requests from authorized study team members for each study.
- Establish appropriate work procedures/guidance, logs, templates, quality procedures, risk impact assessment mitigation procedures, to maintain audit readiness, data integrity, security, consistency and transparency across programs.
- Support preparations and follow-up actions related to internal audits and health authority inspections.
- Contribute to the development, maturity, and consistent application of external data vendor access standards across DS clinical programs.
- Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, work procedures, external data oversight plan, and guidelines.
Operational Efficiency / Continuous Improvement:
- Identify opportunities for continuous process and technology improvements, defining and implementing the changes for improved quality, integrity, and compliance.
- Establish metrics to help determine the efficiency, quality, and consistency of user access and data security through study close-out.
Education and Experience
Education Qualifications (from an accredited college or university):
- Bachelor's Degree required
- Master's Degree preferred
- Minimum of 5 years of Global Clinical Trial Experience in the device/pharmaceutical/CRO industry with expertise in CDR systems including best practices of data security, role & security model design, hierarchical security, compliance and CAPA response & management
- Knowledge of industry standard clinical technologies including, EDC, Clinical Data Repository
- Knowledge of CDASH and CDISC data standards
- Knowledge and understanding of data acquisition and integration tools and technologies
- Knowledge of data snapshots, data cuts and data views required
- Ability to multi-task and work in a fast-paced environment
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.