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Manager, EDC System Integration and Support

Employer
Daiichi Sankyo
Location
Basking Ridge, NJ
Start date
Sep 10, 2022

View more

Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country
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Job Details

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 Integration and Support

Job Summary

The Manager, EDC System Integration and Support will be a member of the Biostatistics and Data Management team and provide subject matter expertise, technical support, and guidance in the use of Electronic Data Capture (EDC) 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. This position will manage all EDC system integration activities to support internal and cross-functional business needs conformant with applicable GxP requirements, global regulations, and data privacy laws. In addition, the individual will also engage in EDC administrative and operational improvements, provide oversight, and contribute to the integration design specifications, manage functional and user acceptance testing, and risk management. 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, Medical Imaging module, and eConsent.

  • Serve as a subject matter expert and manage all EDC system integration activities with the internal suite of products as well as other external systems including Safety System, CTMS, IRT, Clinical Sample Management System, platforms used for third party adjudication, and Data lake.
  • Assess critical data points required for system integrations; identify applicable data point(s) restrictions for implementation in conformance with the blinding guidance and relevant business rules.
  • Determine the GxP requirements (encryption, audit trail, access controls) around data movement, temporary storage, and final resting location in strict adherence to global regulations and data privacy laws. Establish guidelines and requirements to support the evaluation of integration needs in scope of the business needs.
  • Review integration strategy, assess optimal integration patterns and risks, perform code review, review test outputs, and recommend for production use.
  • 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.
  • Provide oversight on post-production changes including proactive assessment and mitigation of risks in collaboration with external partners and/or functional service providers.
  • Manage the functional and user acceptance testing deliverables of system interfaces between RAVE and other peripheral systems including IRT, CTMS, Clinical Sample Management System, and Data lake.

2 Review integration specifications, weigh-in on study design elements, and guide the implementation of the RAVE-RAVE Safety Gateway integration with Safety System for all studies in partnership with study builders, study data managers, Safety team, and Medidata.

  • Provide subject matter expertise to manage all Local Lab activities in RAVE; ensure conformance with correct analytes, appropriate units, conversion factors, defining textbook ranges, and coordinating with local labs.
  • Manage and maintain deliverables pertaining to the implementation of the RAVE Safety Gateway and handling of Local Lab activities in RAVE.

3. Develop and/or provide oversight, maintain, and version all integration specifications pertaining to all system integrations with EDC used in clinical studies.

  • Coordinate with the study builders, study data managers, functional service provider(s), and cross-functional teams on the integration touch points relevant for each study.
  • Manage timelines, identify critical activities, assess risks proactively, develop, and implement mitigation plans, and provide status reports.
  • Manage and maintain deliverables pertaining to the oversight of the EDC system in terms of operational use, system uptime with performance, metrics, improvement opportunities, patch releases, and product upgrades.

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

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 iMedidata product suite of tools; experience in Rave Safety Gateway preferred
  • Expertise in the use of RAVE Web Services, REST APIs, and integration patterns
  • 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.

Company

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.

For more information, please visit: www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.

STOCK EXCHANGE: Tokyo Stock Exchange

STOCK SYMBOL: 4568

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Find Us
Website
Phone
(908) 992-6400
Location
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States
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