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Manager, Study Management Systems (TEMPORARY)

Location San Rafael, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives. 

Duties


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 BioMarin intranet department webpage

    • Contribute to GMAF, Study Management, SOP development and process improvement initiatives relevant to technology

Skills



    • 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

Education


BA/BS or higher in computer sciences preferred



We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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San Rafael

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