Manager, EDC System and Data Management Support in Basking Ridge at Daiichi Sankyo

Date Posted: 11/14/2022

Job Snapshot

Job Description

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.

Manager, EDC System and Data Management Support

Job Summary

The Manager, EDC System and Data Management Support will be a member of the Biostatistics and Data Management team and provide technical support and guidance in the use of Electronic Data Capture systems and other related technologies for clinical studies. The individual will support study data management teams in the optimal use of technology, process, data standards, and reporting across the project portfolio. In addition, this position will engage in EDC administration and operational activities, review design specifications, assess and mitigate risks as needed, provide oversight on post-production changes and migration activities, and facilitate functional and user acceptance testing. This position will work closely with other members of the Biostatistics and Data Management, external CRO partners, functional service providers, and other stakeholders.    

Responsibilities

1.           Serve as a subject matter expert for Data Management Systems and Processes with expertise in the use of iMedidata platform and suite of products including Medidata RAVE, Lab Administration Module, Medidata Coder, Medidata TSDV, RAVE Safety Gateway, and Medical Imaging module.

  • Provide oversight, technical support, and guidance to the study teams in the efficient use of the iMedidata product suite in the study planning, execution, close-out activities and decommissioning of clinical studies.
  • Extend support for Medidata RAVE administrative and operational activities including user management, periodic access review, reporting, and control as needed.
  • Provide insights and support to the study build and edit check programming tasks including optimal use of custom function(s) implementation and testing.
  • Review eCRF and data validation specifications from a technical perspective in consultation with the study teams.
  • Provide technical support for the external data definition, collection, transfer, and storage.
  • Provide oversight on post-production changes including proactive assessment and mitigation of risks in collaboration with external partners and/or functional service providers.
  • Support high quality study builds and edit check programming tasks through proactive oversight, review, and execution of functional and user acceptance testing.
  • Support, review, and contribute to the functional and user acceptance testing of system interfaces between RAVE and other peripheral systems including IRT, CTMS, and Clinical Sample Management System.                    

2            Build and test programs for data validation derivation procedures, data reports, listings, and SAS On-demand Relational Database Extracts for operational use and quality inconsistencies.

  • Support Lab Administration tasks in RAVE, including lab ranges data collection, review, updates, and maintenance.
  • Provide Clinical Programming expertise and support for critical and time-sensitive study milestones including interim analysis, and database lock activities as needed.                

3.           Develop and maintain mapping, and program specifications for standard reports, listings, and visualizations.

  • Develop and build custom report specifications and reports in BO4, J-review or other reporting and visualization tools and facilitate periodic distribution of such reports.
  • Contribute to the development, maturity, and consistent use of data standards across DS clinical programs.                        

4.           Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, work procedures, external data reconciliation oversight, and guidelines.

  • Mentor support team through proactive guidance, advice, feedback, training, and support.                        

Qualifications:

Education          

  • BA/BS degree required, MS or equivalent degree preferable.

Experience        

  • Minimum of 5 years 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 (RAVE, InForm, Veeva)
  • Knowledge of industry clinical data standards including CDISC, Lab CDASH, HL7, LOINC data standards
  • Knowledge and understanding of relational databases

Competencies       

  • Clinical Programming, Project Management, and Technical Expertise
  • Study build and Edit check programming in Rave Architect.
  • Expert knowledge of standard programing tools e.g., SAS, R, Python.
  • Expert knowledge of Rave Custom function and Rave Web Services
  • 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.