Associate Director, Data Management Operations in Basking Ridge, NJ at DSI

Date Posted: 3/13/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

Job Summary:

The Associate Director, Data Management Operations is a member of the Biostatistics and Data Management team and serves as a subject matter expert for Clinical applications, Standards, Process, and Quality. Besides being accountable for the quality of clinical database development, and database standards, the individual will provide subject matter expertise in the use and management of clinical systems, contribute to data management process improvements, and work to ensure quality deliverables in collaboration with DSI Information Technology, CRO Partners, and other stakeholders. The individual will also provide guidance and expertise on industry best practices applied to data management, study teams, and other stakeholders in the use of technology, data standards, processes and improve quality to deliver enhanced business capabilities and efficiencies. This position will work closely with other members of the Biostatistics and Data Management teams, external CRO Partners, and other stakeholders.

Responsibilities:
  • Serve as a subject matter expert and provide expertise for EDC, CTMS, CDR, eTMF and other Data Management systems, Standards and Processes.
  • Manages the quality of the data management clinical database development including edit checks programming and serve as the key contact for matters pertaining to data management technology, quality & process related issues and resolutions.
  • Provide recommendation(s) and decision(s) for Global Standards to ensure consistencies across studies. Adhere to compliance methodologies and metadata management.
  • Work closely with the CRO partners to ensure timely delivery of EDC database, external data, data management programming of reports and listings including the use of Spotfire or other visualization tool.
  • Support the integration of clinical data from various sources including EDC to enhance efficiencies and quality of data management processes and deliverables.
  • Engage with local/global teams on initiatives of importance for Biostatistics and Data Management as appropriate.
  • Oversee the EDC User Administration role to support operational deliverables under Study Set-Up, Study Maintenance, Study Conduct and Study Close Out.
  • Lead and manage external vendors and ensure accurate and high-quality deliverables on clinical database development, database programming, reports and metrics.
  • Plans and directs the study build and project management of data management activities for projects/studies through outsourcing and working with third party vendors.
  • Drive continuous process improvement activities aimed at maximizing efficiencies and improving overall quality of deliverables through lessons learned, industry trends, and experiences.
  • Work with DSI Information Technology, DSI Quality, and other partners to ensure and maintain applications used by Biostatistics and Data Management in accordance with DSI Computer Systems Validation Policy.
  • Mentor and train other data associates within Data Management, as necessary.
  • Participates in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
  • Stay current on industry trends, data standards, and clinical technologies of importance for cancer enterprise and contribute to enhancing business capabilities and operational efficiencies.
  • Establish and implement data standards and comply with regulatory requirements among project team members and across all studies.
  • Partner with DSI Information Technology and other stakeholders in the end-to-end implementation of technology solutions for Biostatistics and Data Management to deliver on enhanced business capabilities and efficiencies.

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

Education/Experience:

BA/BS degree required
  • Minimum of 7 years in the bio-pharmaceutical industry with strong understanding and expertise in areas of data management processes, data standards, technology, and quality.
  • Expertise in EDC RAVE and/or other industry standard EDC platforms
  • Strong knowledge of industry standard clinical technologies including CTMS, eTMF, IRT, and CDR
  • Strong knowledge of data standards; CDASH, SDTM, CDISC
  • Strong knowledge and experience in computer systems validation, 21-CFR-Part11 compliance, drug development, and GxP is required
  • Expertise with reporting tools; J-Review, Spotfire, SAS tools are preferred
  • Experience in handling and processing external data is preferred

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.