- Excellent employment opportunity for a Clinical Data Analyst II in the Diamond Bar, CA area.
- Collaborate with Data Management leadership (including Programming and Biostatistics) to implement data and process standards.
- Provide in-house expertise in the utilization of all system deliverables for clinical trials.
- Support the development and maintenance of global harmonized processes and procedures for system support.
- Support vendor evaluation, selection, contracting, and oversight activities for outsourced systems; Assist with vendor evaluation and selection activities for clinical systems.
- Work with BSDM partners, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines and milestones for study-specific systems set-up, UAT, maintenance and closeout as required.
- Lead project management activity related to the deployment of Interactive Voice/Web Response Systems (IxRS), Electronic Data
- Capture (EDC) Systems, CTMS, eTMF and other relevant platforms (as assigned).
- Create, review and approve system deliverables and facilitate appropriate quality review where applicable.
- Mentor peers through review of deliverables to minimize delays during the quality review process.
- Interface between Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools.
- Provide design input to implement clinical system solutions.
- Serve as first line of support from study initiation through go live for each clinical study. Systems may include: CTMS, eTMF, IxRS, EDCs
- Facilitate the development of training materials and programs related to system set-up, UAT and ongoing maintenance as well as other relevant processes
- To be considered for a Clinical Data Analyst II job opportunity a Bachelor’s degree in Statistics, Computer Science or related discipline (required), with at least 6 years of system support in clinical research within Medical Device or Pharmaceuticals.
- Experience with EDC, CTMS, eTMF and IxRS and integration of systems is required.
- Demonstrated ability to collaborate in a team environment to deliver critical milestones.
- Strong proficiency in more than one Clinical system. Advanced certification preferred.
- Experience with CDISC STDM preferred.
- Excellent verbal and written communication skills.
- Knowledge of GCP and SDLC.
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