Clinical Systems Administrator at Softworld Inc

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.