Clinical Systems Administrator
7 days ago
Job Summary:
Dice is seeking a highly skilled Clinical Systems Administrator to lead the User and Site Account Administration within all clinical systems across the clinical platform. This role will be responsible for initiating best practices and processes related to user and site account management.
Key Responsibilities:
- Perform activities related to User and Site Account Administration within all clinical systems (i.e., EDC, IRT) across the clinical platforms for internal and external stakeholders.
- Perform Clinical System Account Creation/management and Issue resolution.
- Work across the portfolio with the Clinical Study Teams to manage clinical system reporting; perform as primary liaison for both standard recurrent reports, as well as ad hoc report requests.
- Ensure effective communication and issue escalation internally and with external vendors.
- Participate in User Acceptance Testing (UAT) across the clinical platforms.
Requirements:
- Bachelor's Science Degree in Computer Science, Bioinformatics, Business Information Systems, or a relevant technical field or equivalent technical experience.
- 2-5+ years of Clinical Information System management experience, including systems such as EDC, IRT, and eTMF experience.
- Experience managing Clinical Information System vendors such as iMedidata, Endpoint Clinical, and Suvoda.
- 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 Google Cloud Platform 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, and scheduling.
- Excellent communication skills and strong customer focus with the ability to interact in a cross-functional organization and team environment.
- Ability to communicate effectively with external vendors, including issue escalation, and responding to inquiries and concerns.
- Must be able to work in a fast-paced environment with demonstrated ability to prioritize multiple competing tasks.
- Some holiday and weekend coverage may be required.
- Advanced computer proficiency.
- Demonstrated ability to be flexible and to adapt quickly to change, a high degree of initiative, commitment, and persistence.
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