Test and Validation Lead - Clinical Trials Platform - £65K - Remote / Hybrid

Overview:
An excellent opportunity has arisen with an exciting Life Science organisation for a Test and Validation Lead to ensure that technology is safe, validated, and trusted.

The successful candidate will be responsible for creating and maintaining an efficient and effective Quality Management System covering the continuous development and validation of Clinical Trials Management Platform.

Role and Responsibilities:

Develop and maintain an efficient and effective Quality Management Strategy and System for the continuous development of the Clinical Trials Management Platform, ensuring patient safety and meeting regulatory requirements.
Develop and maintain Test and Validation practices, processes, procedures, and templates for quality assurance activities related to the Clinical Trials Management Platform.
Review and approve Test and Validation Strategies, Plans, and Validation Reports developed by platform delivery and platform quality assurance teams.
Prepare, Facilitate and Coordinate User Acceptance Testing, coordinating with third-party development and quality assurance teams as necessary.
Plan and undertake validation of trial specific configurations of the Clinical Trials Management platform obtaining required approvals from the Trial Manager.
Ensure that testing, verification, and validation activities, including generation of documentation are automated is much as is reasonably possible, working with Suppliers and the DevOps Lead to adjust processes and tools as necessary.
Support and coordinate audits and assessments of Clinical Trials Management Platform as necessary.
Perform vendor audits and assessments as necessary.
Manage internal & external stakeholder relationships and report to stakeholders on technology investments.
Exercise cost control and manage expenditure to work within agreed operating budget.
Essential Skills and Experience:

Broad software quality assurance experience and experience in software verification and validation within healthcare or pharma.
Experience in establishing quality management systems aligned with the FDA General Principles of Software Validation, preferably in a setting using an Agile delivery methodology.
Significant experience working with software development and platform configuration teams following Agile and DevOps practices.
Able to work hands-on, with direct experience developing test and validation functions, putting in place practices, processes and documentation, and evolving them within a growing organisation.
Knowledge of TIR/45, FDA Guidance on Principles of Software Validation, NHS Digital Technology Assessment Criteria (DTAC) and / or NHS DCB0126 and DCB0160 desirable.
Package:

£65.5K basic salary
Predominantly remote - (1X per month trips to the office)
Pension contribution
Life Assurance
Income Protection
Private Medical Insurance
Test and Validation Lead - Clinical Trials Platform - £65K - Remote / Hybrid