Clinical Systems Administrator
4 months ago
JobDescription:
- Our client is seeking a ClinicalSystems Administrator to lead the User and Site AccountAdministration within all clinical systems across the clinicalplatform.
- This position will initiate bestpractices and processes related to user and site accountmanagement. This role will report to the Sr. Manager, Clinical DataSystems.
Here's WhatYou'll Do:
- Perform activities related User andSite Account Administration within all clinical systems (i.e; EDC,IRT) across the clinical platforms for internal and externalstakeholders.
- Perform Clinical System AccountCreation/management and Issue resolution.
- Workacross the portfolio with the Clinical Study Teams to manageclinical system reporting; perform as primary liaison for bothstandard recurrent reports, as well as ad hoc reportrequests.
- Ensures effective communication andissue escalation internally and with externalvendors.
- Participate in User Acceptance Testing(UAT)across the clinical platforms.
Skills, Education andExperience:
- Bachelor's Science Degree inComputer Science, Bioinformatics, Business Information systems orin a relevant technical field or equivalent technicalexperience
- 2-5+ years of Clinical InformationSystem management experience including systems such as EDC, IRT andeTMF experience
- Experience managing ClinicalInformation System vendors such as iMedidata, Endpoint Clinical,and Suvoda
- Prior experience working withmultiple Clinical Information Systemssimultaneously.
- General knowledge of FDA andother global clinical trial regulations, as well as detailedknowledge of ICH and FDA Google Cloud Platformguidelines
- Detailed knowledge of FDA CFR Part11 regulations
- Good organization and projectmanagement skills with a demonstrated ability to workindependently, take initiative, complete tasks todeadlines.
- Requires strong attention to detail,document organization skills andscheduling.
- Excellent communication skills andstrong customer focus with ability to interact in a crossfunctional organization and teamenvironment.
- Ability to communicate effectivelywith external vendors, including issue escalation, and respondingto inquiries and concerns.
- Must be able to workin a fast-paced environment with demonstrated ability to prioritizemultiple competing tasks.
- Some holiday andweekend coverage may be required.
- Advancedcomputer proficiency
- Demonstrated ability to beflexible and to adapt quickly to change a high degree ofinitiative, commitment, andpersistence.
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