Manager, EDC Database Programming

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, EDC Database Programming is a member of the Biostatistics and Data Management team and serves as a subject matter expert for the oversight, guidance, and design of study build activities for all clinical studies Electronic Data Capture systems and other related technologies, Clinical Data Programming and Reporting. The scope of work includes ownership and oversight of the study design, build, edit check and custom function programming activities, including the review of CRF specifications and data validation specifications.

In addition, the position involves assisting with functional and user acceptance testing, and managing quality deliverables in partnership with RAVE Administrator, Study Data Managers, and functional service providers. The individual will also engage in the governance, management, and advancement of DS Global Library Standards. This position will work closely with other members of the Biostatistics and Data Management, external CRO partners, service providers, and other stakeholders.

Responsibilities

Leadership, Direction, and Strategy:

• Provide Guidance and manage accountability for the study build activities ensuring high quality, consistency, and adherence to eCRF Specifications established for each study.

Project Management:

• Manage all study build deliverables for the timely delivery and implementation of high-quality study builds for all studies in conformance with DS standards and eCRF specifications for the study.
• Manage and maintain administrative, operational deliverables, and timelines pertaining to study build activities, edit check programming, custom function development - including proactive review, testing, and supporting documentation to ensure high quality study builds for all studies.
• Collaborate with the study data managers, external CROs, and service providers to ensure study build configuration is reviewed, tested, and completed with high quality in a timely manner.
• Guide the operational execution of the steps and procedures for consistency and accuracy pertaining to the delivery of high-quality study builds for all studies.
• Proactively identify and resolve issues that may influence and/or impact study build quality and other deliverables.

Functional Expertise:

• Serve as a subject matter expert and provide oversight, guidance, and design of study build activities for all studies.
• Establish and confirm design specifications of study build activities including core configuration, eCRFs, Data Validation Specifications (DVS), and Reporting.
• Establish and confirm the configuration of the EDC study build in conformance with study design specifications for eCRFs, DVS, Custom Functions, tSDV, Integrations, and Reporting.
• Establish and implement edit check and custom functions programming standards.
• Review and provide input to quality database designs for fit and feasibility within the EDC application and ensure consistency with established standards.
• Ensure that the system interfaces are designed and configured for optimal use and not in conflict with the study build and relevant specifications for all studies.
• Lead and/or provide oversight to functional and user acceptance testing activities including edit check and custom function test scripts, programming, and validation tasks; CRF screens for the study conforms to the CRF specifications, and configuration.
• Lead and/or Provide oversight on the impact analysis and risk assessment of study build change requests, maintain documentation, and facilitate the implementation of changes as per the change control procedures.
• Track, debug, and resolve issues pertaining to study build and programming tasks for all studies.
• Engage in the governance, management, and advancement of the DS Global Data Standards across the project portfolio.

Operational Efficiency / Continuous Improvement:

• Identify opportunities for continuous process improvements, improve work procedures, QC procedures, checklists to track milestones, status, and issues; ensure traceability, and study build performance metrics.
• Contribute to the development of content and training pertaining to all aspects of the study build activities in partnership with the study data managers and the functional service provider(s).

Qualifications

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.

Education

• Bachelor's Degree or higher in life sciences or related field required
• Master's Degree or equivalent in life sciences or related field preferred

Work Experience

• Minimum of 5 years of EDC study build and database programming experience and data validation programming in the device/pharmaceutical/CRO industry; expertise in Clinical Programming, methods, and techniques; knowledge of industry standard clinical technologies including CTMS, EDC, Clinical Data Repository (CDR); knowledge of CDASH and CDISC data standards; knowledge and understanding of data acquisition and integration tools and technologies. required

Competencies

• Work collaboratively with people at different levels of experience, different disciplines, and cultures
• Self-directed; able to work independently
• Strong communication, negotiation, and conflict resolution skills
• Ability to manage multiple priorities
• Strong background in Clinical Programming, Project Management, and data acquisition methods
• Study build and edit check programming in Medidata RAVE Architect
• Medidata RAVE Custom Function Development Experience and knowledge of RAVE Web Services (RWS) desirable
• 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.