Validation Analyst - Computer Clinical Systems - Uk – Office Or Home Based

Who we are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What Clinical SystemsValidation Analyst does at Worldwide
The Validation team are responsible for the Validation lifecycle activities for computer systems used as part of a clinical study. The lifecycle encompasses system selection, assessment phase (requirements and risks), implementation phase (validation deliverables, review of testing, release documentation), operational phase (change control, disaster recovery, access and periodic review) and decommission phase (data retention).
A Validation Analyst will assist in these activities supporting the Senior Validation Analyst and the Manager System Validation to ensure the computer systems comply with regulatory and Worldwide expectations.
What you will do

• Author computer system validation documentation
• Catalogue and track project-specific validation documentation
• Tracking periodic review activities, including but not limited to disaster recovery and access reviews
• Responsible for collating and reporting metrics and preparing materials for Worldwide audits

What you will bring to the role

• Ability to communicate concisely and effectively in both written and spoken English
• Problem Solving and Relationship Management skills
• Proficient in the use of common office software
• Self-motivated individual who can positively contribute to a team environment
• Ability to prioritize and handle multiple projects simultaneously
• Ability to demonstrate attention to detail

Your experience

• Educated to degree level in a relevant discipline (Computing / Scientific) or able to demonstrate equivalent experience and at least 2 years’ experience within a computing, testing, scientific, quality or compliance environment.
• Experience of document authorship and control
• Ideally experience of working within organizations employing GAMP, GxP, ISO standards. Ideally pharmaceutical industry, CRO, Clinical or Lab experience.
• Basic understanding of clinical trials, blinding, patient safety, data integrity and associated regulations

We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at www.worldwide.com/careers ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .