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Clinical Technology Implementation Specialist
2 months ago
About This Role:
The Clinical Technology Implementation Specialist will lead the implementation of technology at a clinical trial's outset, ensuring timely start-up, quality delivery, and compliance with the study protocol and client contracted services.
Key Responsibilities:
- Lead the UAT Testing of the eClinical platform for a study
- Serve as the primary point of contact internally and with external customers as needed for UAT delivery
- Collaborate with Project Leaders, Project Specialists, and other study team members on UAT Testing needs from the point of early trial planning through trial execution
- Analyze protocols and collaborate with all stakeholders to create and review user requirements and integration needs from the perspective of UAT testing
- Identify and mitigate any risks related to system set-up and integrations with internal systems and/or sponsor systems and implement appropriate testing scenarios to mitigate risks
- Focus on timely, high-quality delivery of all services provided
- Stay current on the latest Parexel technology offerings, integration issues, and relevant clinical trial process developments in the industry
- Interact with external clients as needed for discussion on technology set-up, UAT testing, modifications, and integrations
- Demonstrate a proactive approach to providing solutions in a timely manner
- Maintain a positive, results-oriented work environment, modeling teamwork, and communicating with team members in an open, balanced, and objective manner
- Maintain a working knowledge of applicable ICH Guidelines and Good Clinical Practices
- Complete routine administrative tasks in a timely manner (e.g., timesheets, training) and in compliance with relevant guidelines
Requirements:
- Several years of life science industry experience (CRO/Pharma)
- Experience in leading eclinical software testing
- Experience in IRT/RTSM and/or Digital Health Technology system delivery
- Ability to manage independently competing priorities with attention to detail
- Ability to learn new systems and function in an evolving technical environment
- Global virtual team coordination experience for trial technology set-up
- Excellent verbal and written communication skills
- Ability to work to timelines
- Fluent English
- Strong customer focus
- Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
