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The Senior Clinical Systems Administrator will act as a subject matter expert for Clinical Systems, collaborating with the Clinical Systems Manager and IT to ensure successful adoption across the organization. Key responsibilities include updating and managing templates, handling help desk tickets, creating processes and procedures, overseeing system integrations (especially with EDC) and archival steps, and supporting end-users. The role also involves assisting with system configuration changes, new version releases, testing, validation, user acceptance testing, and end-user reviews. Additionally, the administrator will participate in audit preparations and CAPA plan development, and support managers with ad-hoc tasks. The ideal candidate will have a degree or equivalent experience in business, scientific, or healthcare, with at least 5 years of experience in Clinical Systems and a deep understanding of clinical trial systems (CTMS, EDC, eTMF, RTMS), including requirements gathering, configuration, and integrations. Skills in issue resolution, independent learning, and strong communication are essential.
Position Summary:
The Senior Clinical Systems Administrator will serve as a subject matter expert over Clinical System. This position will collaborate with Clinical Systems Manager and IT to define and deliver successful adoption across the organization.
Essential functions of the job include but are not limited to:
•Responsible for working with the Clinical functions to update and add templates into the Clinical Systems
•Manages help desk ticket assignment to the Clinical Systems Administrators
•Create Clinical System processes and procedures
•Oversees the integrations between the Clinical system and Electronic Data Capture system
•Performs archival steps within the Clinical System as the request was received.
•Serve as a Clinical Systems subject matter expert (SME) and support end user requests.
•Collaborate with functional teams to updates Clinical systems configurations, i.e. templates, reports, dashboards, and/or milestones.
•Assist with Clinical System new version releases and configuration changes, including testing, and validation oversight or as needed User Acceptance Test (UAT) execution.
•Manage end-users ongoing reviews.
•Provides oversight of the EDC integrations with the Clinical System
•Support the creation of Clinical System processes, procedures and trainings for the functional teams and external teams.
sponsor and/or site staff, to ensure that study teams have the guidance needed to work CTMS
features independently and meet periodically with study teams to offer ongoing support.
•Participate in inspection/audit preparation activities and assist in the development /
execution of CAPA plans, when applicable
•Support the Clinical Systems principal or manager in any ad-hoc tasks assigned
Qualifications:
Minimum Required:
•Degree, or equivalent experience ideally in a business, scientific or healthcare discipline
•5 years of experience with Clinical Systems
Other Required:
•Experience in clinical trial systems (e.g., CTMS, EDC, eTMF and RTMS) with detailed understanding of requirements gathering, documentation, configuration and integrations
Preferred:
• Prior experience in a Clinical Operations role, handling clinical systems
• Possess the ability to effectively communicate business needs to IT technology partners.
Skills:
•Ability to resolve issues independently with good judgement to escalate appropriately.
•Ability to learn new systems and integration requirements.
•Strong interpersonal, verbal and written communication skills
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