Clinical Systems Administrator

4 weeks ago

Boston, United States Softworld Inc Full time

Job Title: Clinical Systems Administrator

Location: Remote/ Boston, MA (EST hours)


Duration: Contract/ 12 months with possibility of extension

Job Description:


Our client is seeking a Clinical Systems Administrator to lead the User and Site Account Administration within all clinical systems across the clinical platform.
This position will initiate best practices and processes related to user and site account management. This role will report to the Sr. Manager, Clinical Data Systems.

Here's What You'll Do:

Perform activities related 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.
Ensures effective communication and issue escalation internally and with external vendors.
Participate in User Acceptance Testing (UAT)across the clinical platforms.

Skills, Education and Experience:

Bachelor's Science Degree in Computer Science, Bioinformatics, Business Information systems or in 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 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 and scheduling.
Excellent communication skills and strong customer focus with 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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