Vacancy expired!
BUSINESS ANALYST WITH CLINICAL TRIALLAWRENCEVILLE, NJ Project Description: Provide system administration tasks for global medical information system, including but not limited to testing PI's, adding quick codes, adding & maintaining system dictionaries & drop-down lists, creation of header (images), signature images as well as ad hoc reports from within the application query tools. Provide system administration for medical information system.
- Support in the development, execution, and monitoring of the system/technology Business Plan in collaboration with key stakeholders.
- Partners with R&D functions, internal and external on implementation, and oversight of new and existing platform capabilities.
- Responsible for the development of system and reporting requirements for the Clinical Trial Business Capability in partnership with IT colleagues.
- Support activities for system/technology performance, project budget, stakeholder communications/change management.
- Lead training and communication for stakeholders impacted by change initiatives to the application or system processes for specific capabilities. Liaise with user forums or working groups.
- Partners with the R&D Learning on development of training materials.
- Delivers training to trainers and super-users (train-the-trainer).
- Supports user acceptance testing of system enhancements and upgrades, providing SME advice on testing approach, script writing, review, and approval.
- Lead testing and support validation efforts for business capabilities, including participating in Operational Qualification and Performance Qualification of systems.
- Defining a suitable test strategy and writing test cases to support release management of systems/technologies within a specific clinical trial business capability.
- Participate in system/technology work streams and outcomes in change initiatives.
- Contributes to internal/external continuous improvement initiatives.
- Experience in clinical trial, data, or technology management.
- Knowledge of Clinical Trial Business Capabilities such as eTMF, eConsent, EDC, Clinical Trial Portals, Patient Portals, HCP Portals, eCOA, Clinical Trial Data Warehouse and Clinical Trial Monitoring.
- Knowledge of Google Cloud Platform/ICH guidelines, regulations
- Proficient computer skills required (MS Word, excel, PPT).
- Excellent communication skills required.
- Knowledge of medical terminology preferred.
- Attention to detail a must.
- Ability to perform business administration and operational support tasks.
- Competent Business process knowledge of Investigator Initiated Trials / Investigator Sponsored Studies.
- Familiarity with Agile Project management.
- Project Management skills a plus.
- Previous experience with Change Management activities, process development and workflow management.
- College degree.
Vacancy expired!