[Hiring] Clinical Systems Lead @Worldwide Clinical Trials

Role Description

Act as the functional lead for delivery of one or more clinical system study implementations.

• Collaborating with the project manager to track and report project status.
• Leading the effort to deliver the necessary study configuration and documentation within schedule and to a high level of quality and completeness.
• Providing periodic demonstrations of system functionality to internal and client stakeholders, capturing and resolving issues and requests for change.
• Author clinical system User Requirements Specifications where required.
• Perform configuration and study setup to meet study timelines, fulfill business and technical requirements, and align with SOPs.
• Perform quality control checks and/or lead or participate in testing efforts for study builds (as required by the system’s SOPs) to ensure study build compliance with requirements and SOPs.

Qualifications

• Ability to communicate concisely and effectively in both written and spoken English.
• Proficient client-facing skills.
• Proficient in the use of common office software.
• Able to work independently or in a multi-disciplinary team.
• High attention to detail.
• Able to be creative, adapt to new technologies, concepts and processes, make improvements and solve problems.

Requirements

• Educated to degree level in a relevant discipline or be able to demonstrate equivalent experience.
• 2+ years’ experience in a combination of Contract Research Organization (CRO) experience, CTMS or IRT study delivery, or clinical systems configuration desired.
• Experience working in regulated environments such as clinical trials (GAMP, ISO Standards).
• Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations.

Benefits

• Equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.