Senior Validation Analyst - Fixed Term - UK -Remote

Worldwide Clinical Trials; United Kingdom; Remote; GBP 30,000 - 45,000; Full time

Job summary

A global clinical research organization is seeking a detail-oriented Documentation Specialist to ensure compliance and track project validation documentation. The ideal candidate should have at least 2 years of experience in a relevant environment, effective communication skills, and proficiency in office software. This role plays a crucial part in maintaining data integrity and patient safety within clinical trials.

Qualifications

• 2 years’ experience within a computing, testing, scientific, quality or compliance environment.
• Experience of document authorship and control.
• Understanding of clinical trials and associated regulations.

Responsibilities

• Author computer system validation documentation.
• Track project-specific validation documentation.
• Prepare materials for audits.

Skills

Effective communication

Problem Solving

Relationship Management

Attention to detail

Education

Degree in Computing / Scientific or equivalent experience

Tools

Office software

Job description

Overview

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

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 the Clinical Systems Department does at Worldwide

Our Clinical Systems Department plays an essential role for the entire organization by ensuring our systems are developed to study specifications, fully integrated, optimally running, and well-maintained throughout the studies’ lifecycle. The department works closely with industry specific systems such as: IRT, RTSM, EDC, RBQM Opra , ClinSpark , eTMF and CTMS. The department has various roles including client-facing Project Managers, System and Software Designers, and Implementation and Validation specialists. Each of these areas provides mentorship and training. In working with a variety of systems, the department has a proven record of success for promotions and growth internally.

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
• Responsible for 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
• At least 2 years’ experience within a computing, testing, scientific, quality or compliance environment.
• Experience of document authorship and control
• Experience of working within organizations employing GAMP, GxP , ISO standards.
• Ideally pharmaceutical industry, CRO, Clinical or Lab experience.
• 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 Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.