750 Lindaro Street
Industry: Clinical & Scientific
Job Number: 16123
Bayside Solutions is seeking a Study Management Systems Manager to be part of our client’ s team in San Rafael. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Study Management Systems Manager:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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, and 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
- 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
- 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
- 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, and 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 company intranet department webpage
- Contribute to GMAF, Study Management, SOP development and process improvement initiatives relevant to technology
Summary of Qualifications:
- BA/BS or higher in computer sciences preferred
- 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