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Associate Director, Clinical Systems
Pacira BioSciences, Inc.Parsippany, United Statesfull_timeVerifiedPosted 14 Nov 2024
About the role
About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Why work with us? Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together. Summary:The Associate Director, Clinical Systems will support and develop capabilities for clinical data acquisition and standardization, increase efficiency of database builds, data visualization, and enable compliance to CDISC standards (e.g. CDASH, SDTM) while implementing industry best practices. Essential Duties & Responsibilities:The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned. Clinical Systems Support:
- Expert in clinical systems and platforms (e.g. Medidata, Veeva CDMS, Veeva CTMS, CliqSense, JReview) configurations, capabilities, and system behaviors. Lead and deliver new capabilities, innovative technical solutions and/or clinical system integrations that enable future proof study execution.
- Provide technical leadership focused on technology enablement for EDC, Data Visualization, and other data collection / display systems
- Technical support for system integration, patient facing technologies and data reporting tools (e.g., IRT, ePRO).
- Ensure continuous improvement of processes, tools and outputs to be used to facilitate advancement of study portfolio.
- Liaise with systems vendors to develop and maintain system environments to support the organization.
- Lead efforts to identify future system capability and enhancement opportunities.
- Technical study lead to work with study team counterparts on study deliverables from external partners (e.g. Functional Service Providers, CROs, technology providers) performing data collection and data visualization services on behalf of Pacira.
- Oversee the build, maintenance, and deployment of study databases to collect clinical trial data, including configuring custom integrations if applicable.
- Oversee the build, maintenance, and deployment of data visualizations to display clinical trial data, including configuring custom integrations if applicable.
- Manage work assignments to ensure timely delivery of study databases, data review reporting, external data management, and other study related technical components.
- Collaborate with Data Management to develop appropriate timelines for development and deployment of study databases, visualizations and the management of external data and reporting.
- Identify and resolve technical system issues which may negatively impact delivery of study databases and data visualizations. Escalate issues to leadership as needed.
- Responsible for ensuring the activities required to build out standard objects (e.g., eCRF forms, edit checks, eCRF entry guidelines, standard data review reports) that are compliant with CDISC (SDTM) are implemented
- Collaborate with cross functional core roles (Data Managers, Medical Monitors, Statisticians, Programmers, etc.) to implement new or modified global library objects.
- Develop and monitor key standard clinical systems performance metrics.
- Adhere to procedural documents and participate in reviewing, authoring and/or updating documents reflective of industry standards.
- Develop strong and productive working relationships with key stakeholders with the ability to think strategically across a
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