Quark Pharmaceuticals, Inc.

Location:  Fremont, CA

Job title: Principal Database Programmer

Reports to:  Head, Clinical Data Management

 

Position Summary:

 

The Principal Database Programmer is responsible for managing the delivery and execution of all technical aspects of study build, validation, and maintenance, including core configuration, update and migration activities for ongoing clinical studies, database revisions, timely resolution of technical issues related to the conduct and closeout of clinical studies. The Database Programmer works collaboratively with Clinical Data Management and multiple functional groups to complete programming tasks per agreed upon timelines.

Responsibilities:

  • Serve as a primary technical liaison and subject matter expert (SME) on all Medidata products used on Quark studies for internal/external users and partners
  • Provide database build projections to DM/PM Lead for study timeline
  • Program/configure eCRFs, edit checks, derivations, custom functions (not required), and reports
  • Lead and conduct validation and testing, including Unit Testing and UAT
  • Develop annotated case report forms and End of Study Media
  • Lead conduct of database upgrades and migrations
  • Design, review, and maintain electronic data transfer and integration specifications
  • Maintain appropriate technical and study documentation
  • Facilitate integration with other tools, perform data extracts and batch uploading
  • Troubleshoot and correct found issues in all Medidata modules (as possible)
  • Manage administration of Rave Core Configuration, Report and Lab Administration modules, including implementation and documentation of all changes
  • Support build and modification of Medidata Balance, Rave Safety Gateway and Coder modules
  • Review database, edit check, integration, and report specifications and provide input
  • Ensure compliance with applicable regulatory requirements for data capture and storage, company SOPs and study specific procedures
  • Provide accurate and timely answers to technical questions from peers and clients
  • Effectively communicate with various levels of personnel and keep relevant parties informed
  • Participate in process development initiatives impacting Data Management and systems
  • May provide mentorship to 1-3 programmers and Data Managers
  • Perform other duties as assigned

Qualifications:

  • BA/BS degree in statistics, computer science, biostatistics, mathematics or related field
  • Minimum 5-7 years database design and edit check programming utilizing Medidata RAVE
  • Certified RAVE Study Builder
  • Certified RAVE Study Administrator
  • Experience in iMedidata, Balance, Rave Safety Gateway, Coder, SAS, JReview, BOXII and C# preferred
  • Experience with data export and data acquisition management (lab uploads) preferred
  • Excellent problem solving skills
  • Demonstrated strong attention to detail
  • Basic knowledge of FDA/ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines, the software development lifecycle and 21 CRF Part 11 and other FDA regulations
  • Experience with pharmaceutical industry data standards, such as CDISC/SDTM and ADaM data models