Manager, Study Management Systems

San Rafael, CA 94901

Posted: 07/25/2019 Employment Type: Contract Industry: Clinical Job Number: 6592

Job Description


Responsibilities will include a broad base of technology systems, data, and reporting duties as delegated, which may include, but are not limited to:

Clinical Trial Management System (CTMS)
  • Acts as the primary support for system end users
  • Develop and provide initial and ongoing end user system training
  • Responds to system users, addresses/answers system questions/issues and perform database updates
  • Process, review and document data changes and interactions commensurate with level of database write access for the Application Administrator role per approved procedures
  • Develop system customization specification, user guides, standard and customized system reports
  • Collaborate with Study Teams to develop study specific system use plans
  • Manage documentation creation, revision and retention utilizing Good Documentation Practice (GDP) guidelines
  • Evaluate new CTMS technologies and recommend changes/updates as appropriate to Study Management Leadership

Data Warehouse
  • Collaborate with data warehouse department owners to establish GMAF Study Management customizations
  • Hands on development and management of data warehouse, including integration with external systems and data sources
  • Responsible for processes and operations related to database warehouse maintenance to ensure maximum quality, content, and timeliness
  • Develop and maintain appropriate segmentation and metadata to create and maintain department key performance metrics, standardized reports, and ad hoc analysis

Reporting and Analytics
  • Develop, manage and administer GMAF, Study Management, automated reporting tools, including but not limited to the Power BI, Board, and others
  • Collaborate with GMAF Program and Study Teams, to develop reporting tools that provide relevant stakeholders with meaningful key performance metrics and other relevant analytics
  • Support GMAF Program and Study Teams with the maintenance of data sources

Technology Management
  • Work across GMAF, Study Management, to identify needs, implement, manage and maintain relevant systems and databases, including budget and forecast
  • Participate in technology governance and decision making forums, which are attended by GMAF and cross-functional stakeholder
  • Interface with internal stakeholders and information management, on behalf of GMAF, Study Management, to prioritize, communicate, and continually manage new technology projects, or changes to existing systems
  • Serve as the Subject Matter Expert for GMAF, Study Management, processes that define the use of technology
  • Participate in capturing system business requirements and testing of GMAF, Study Management, technology projects
  • Manage vendors as applicable for systems and technology project(s)
  • Serve as the system lead for key GMAF, Study Management systems such as CTMS, Office 365 (SharePoint), Power BI, Spotfire, electronic collaboration sites and intranet department webpage
  • Contribute to GMAF, Study Management, SOP development and process improvement initiatives relevant to technology


Job Requirements


  • 3 years of relevant experience in system administration, technology management, project management, or study management
  • 3 years of relevant experience with reporting and analysis tools, database management software
  • General knowledge of terminology, principles, methods and procedures of basic medical and/or clinical research
  • Experience working in a GxP or other regulated environment with validated systems
  • Advanced skills with CTMS, Power BI, Office365 (SharePoint), Microsoft Office Suite
  • Some line management experience (0-1 years) preferred



  • BA/BS or higher in computer sciences preferred
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