PRA Health Sciences Looking for UAT / Validation Specialist – Clinical Trials at Remote Full Time

Icon plc is a world-leading healthcare intelligence and clinical research organisationFrom molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our successIcon people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities

Main deliverables:

Responsible for implementation and maintenance of digital health systems that support clinical development activity within the department
Provide subject matter expertise in system implementation, validation, maintenance, and issue escalation
Lead and participate in operational strategy projects
Work closely with other team members to ensure system impact is assessed and mitigation strategies are in place (where applicable)
Develop and maintain a clear understanding of the needs of clinical trials/programs and internal/external stakeholders

System support:

Follow-up and support releases for the technologies/systems in use
Perform user acceptance testing (uat) for each respective technology/vendor system in use
Assess new tools and perform uat of existing and new tools
Identify and write high-quality system test scripts
Review system development lifecycle (sdlc) documentation, as applicable
Evaluate change control plan/report in close collaboration with it
Support system uat automation, where needed
Work with it to re-test defects after a fix has been applied, including regression testing
Support integrations landscape and validation needs
Support vendor oversight, which can include incident/problem management, device provisioning follow-up and escalate as needed
Comply with relevant training requirements
Regularly update information in applicable systems and templates
Support continuous quality improvement efforts by contributing to the development / improvement of departmental procedures, processes, and templates
Maintain quality standards and timelines that are consistent with business needs

Qualifications

Required:

Bachelor’s degree (university degree) or equivalent
At least 2-3+ years of operational experience in clinical trials
Knowledge of clinical development processes, global clinical operations, and strategic planning
Strong systems validation experience and knowledge
Uat and test script writing experience
System requirement gathering experience
Experience with system release management, automation, and maintenance
Passion for digital technologies and how they are implemented into clinical studies
Effective written and verbal communication skills
Good presentational and motivational skills

Preferred:

Prior experience working for a pharmaceutical company or cro
Ability to assess ecoa / epro or other clinical technology needs for new studies, including on-boarding of new vendors
Knowledge of industry best practices for vendor management
Experience with self-service providers, digital platforms, and related technologies
Experience in process improvement and working on related initiatives
Solid project management skills and the ability to lead meetings

Benefits of working in icon:
Our success depends on the knowledge, capabilities and quality of our peopleThat’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At icon, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programsIn addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.
Icon, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassmentAll qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.