I am delighted to work with an exciting and successful fast-growing pharmaceuticals company. That is a global leader in clinical trials. My client offers a fast-paced environment pushing boundaries to the next generation, whilst being able to gain new skills and grow your career.
This role can be done completely remotely from any of the following locations: East coast US, West Coast US, Germany, Netherlands, UK, Switzerland, Ireland and Belgium.
Key Accountabilities of the Software Test Analyst include the following:
Testing of client RTSM applications to enable client start-up targets
Work with Client Services Lead to ensure study level applications are tested appropriately to deliver a high quality, validated system to clients.
Responsible for project level validation to ensure study application is developed, tested and deployed as per the companies SOPs
Work with Client Services Lead to identify study customisations required, if any, to ensure that an impact assessment can be properly conducted as per the companies SOPs and that the study testing strategy reflects this
Develop study specific validation plans, test strategies and test cases
Execute study testing, following SOPs
Develop study specific validation reports
Prepare the system for UAT and production, in coordination with the development team as necessary.
Provide support to Client Services Leads for day to day operations in support of RTSM applications
Responsible for operational testing required for study applications (system / data changes) as per SOPs.
Participate in client audits
The position requires a minimum of 2 years’ experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation.
Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11, and associated regulatory guidance documents.
EDUCATION AND/OR CERTIFICATION REQUIREMENTS
The candidate must possess at minimum a bachelor’s degree in a life sciences, supply chain management, or information technology field, or equivalent experience.
Software testing experience is a plus
Experience with IRT/RTSM and clinical supplies forecasting/simulation tools is a plus.
Experience working with agile development methodology is a plus.
Leadership Competencies; Client focused, solutions focused, proactive, responsive, organized, highest quality deliverables. Excellent verbal and written communication skills.