Clinical Information Specialist
30 Enterprise Suite 400 Aliso Viejo, CA 92656
Provides functional support for the support of Clinical Operations Clinical Information Systems, including but not limited to: Clinical Trial Management System (CTMS), Electronic Trial Master File System (eTMF) and other Clinical Operations Information Systems as they become available. The CISS will primarily perform daily tasks in support of the Clinical Operations Clinical Information Systems
The CISS will be monitoring the CTMS / eTMF support queue for routine maintenance issues and completing them or escalating those that are not routine. The CISS is also responsible for appropriately handling clinical study records (e.g. clinical Trial Master File) or Clinical Operations Clinical Information Systems in compliance with company SOPs and process with a focus on inspection readiness required for regulatory agency inspection and internal audits.
- Responsible for routine maintenance of the Clinical Operations CTMS (including Payments) / eTMF and Grants Manager
- Monitor the Clinical Operations CTMS / eTMF request e-mail queue
- Checking the status of the daily background jobs for completion and fixing any errors.
- Act as knowledge source for all Clinical Operations CTMS / eTMF / Grants Manager End User activities
- Participate in CTMS / eTMF / Grants Manager User instructions development, implementation and maintenance
- Act as a trainer for Clinical Operations CTMS / eTMF / Grants Manager user training as needed
- Act as a point-of contact for Clinical Operations staff CTMS / eTMF / Grants Manager user support needs
- Participate in CTMS / eTMF sub-teams as assigned
- Participate in CTMS / eTMF validation activities as assigned
- Manage CTMS / eTMF / Grants Manager reporting; both standard recurrent reports, as well as ad hoc report requests
- Participate in the identification, evaluation, selection, development, implementation and maintenance of new Clinical Operations Clinical Information Systems as assigned.
- Ensures effective support of the Clinical Operations staff CTMS / eTMF / Grants Manager systems through effective communication and issue escalation with vendor resources.
- Bachelors Degree (or equivalent) in relevant field of study such as Bioinformatics, Health Administration, Business Information Systems, or Business Administration.
- 3 to 5+ years of Clinical Information System management experience including CTMS and eTMF experience
- Experience managing Clinical Information System vendors
- Previous experience as Clinical Trial Administrative Assistant or Clinical Research Associate is highly desirable
- Prior experience working with multiple Clinical Information Systems simultaneously
- General knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines
- Detailed knowledge of FDA CFR Part 11 regulations
- Good organization and project management skills with a demonstrated ability to work independently, take initiative, complete tasks to deadlines.
- Requires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines.
- Solid communication skills and strong customer focus with ability to interact in a global, cross functional organization.
- Ability to communicate effectively with external vendors, including issue escalation, and responding to enquiries and concerns.
- Must be able to work in a fast paced environment with demonstrated ability to prioritize multiple competing tasks and demands.
- Advanced computer proficiency
- Demonstrated ability to be flexible and to adapt quickly to change a high degree of initiative, commitment and persistence.
Able to use computer.
Specific vision abilities required by this job include Close vision and ability to adjust focus.