Manager Clinical Database Application & Reporting
Daiichi Sankyo, Inc.

Job Info

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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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

Job Summary:

The Manager, Clinical Database Application and Reporting is a member of the Biostatistics and Data Management team and serves as a subject matter expert for Electronic Data Capture systems and other related technologies, Clinical Data Programming and Reporting. This position will provide oversight, technical support, and guidance to the study teams in the optimal use of Medidata suite of products including iMedidata, RAVE, Lab Administration Module, Medidata Coder, Medical Imaging, RAVE Safety Gateway, and Medidata TSDV solutions. Engage in RAVE administration activities as needed, assist in user acceptance testing, and manage quality deliverables in partnership with DSI RAVE Administrator, DSI Quality, DSI IT Service Management, and CRO Partners. The scope of work also includes assisting in the Governance and Management of DS Global Library Standards. This position will work closely with other members of the Biostatistics and Data Management, external CRO partners, and other stakeholders.

Responsibilities:

• 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, and close out activities of clinical studies.
• Expertise in executing iMedidata Administration Tasks - including site and user administration, RAVE Coder Administration, assisting study data managers in completing the study lock activities, and participating in internal audit and inspection activities, as needed.
• Expertise in the development, support, and optimal use of the RAVE Custom Functions.
• Engage in the Governance and Management of DS Global Library Standards; maintain and support DS Global Standards documentation.
• Contribute to the build and edit check programming of the RAVE Standard Libraries

• Manage all quality deliverables including documentation to ensure the validated state of the product in partnership with Medidata, DSI Quality, and DSI IT Service Management

• Engage in the review of QA audit findings; propose efficient corrective and preventive actions (CAPA) proactively working with internal and external stakeholders.
• Work closely with the study teams to develop specifications, support adhoc reporting needs, and facilitate user acceptance testing in partnership with internal and external stakeholders, as needed.
• Partner with internal and external stakeholders to ensure timely delivery of data management programming, EDC database, external data, data management programming of reports and listings including the use of Spotfire or other visualization tools.
• Contribute to the quality of the data management clinical database programming deliverables including edit checks programming, complex reports, and listings; patient profiles, subject narratives, exception listings, dose modification reports, and other adhoc reports, as required by the study teams.
• Builds/tests programs for data validation derivation procedures, data reports, listings, and SAS On-demand Relational Database Extracts to identify inconsistencies and support clinical data review activities.
• Provide technical expertise and programming support for Medical Coding activities.
• Provide Clinical Programming expertise and support for critical and time-sensitive study milestones including interim analysis, and database lock activities.
• Perform ETL tasks, enhancements, validation, and maintenance of the programs and templates on an ongoing basis.
• Perform QC, develop validation scripts for user acceptance, execute programs and reports as needed, in preparation of user acceptance activities and in support of critical study milestones, as needed.
• Develop and maintain mapping, and program specifications for standard reports, listings, and visualizations.
• Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.
• Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

BA/BS degree required, MS or equivalent degree preferable.
Minimum of 5 years EDC trial 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)
Knowledge of CDISC data standards
Knowledge and understanding of relational databases

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.

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