Worldwide Clinical Trials

Senior Validation Analyst

Nottingham, GB
11 Sep 2020
25 Sep 2020
Full Time
Contract Type
Experience Level
Experienced (non-manager)
SUMMARY: To co-ordinate and perform validation and maintenance activities for Worldwide's GxP systems. To represent Worldwide's in sponsor audits and regulatory authority inspections.

  • Oversee the validation status of Worldwide GxP systems
  • Develop validation strategies for new or modified systems
  • Author, review and approve computer system validation documentation
  • Catalogue and track project-specific validation documentation
  • Track and report on all technology-related compliance activities
  • Assist in training and mentoring Worldwide team members in the technical competencies of validation and the authoring of validation deliverables
  • To review existing approaches to Worldwide SDLCs with a view to improving procedures
  • Develop and implement QMDs associated with validation
  • Responsible for preparing materials for Worldwide audits
  • Assist on sponsor audits

  • Ability to communicate concisely and effectively in both written and spoken English
  • Ability to create and deliver training materials
  • Proven stakeholder management skills
  • Strong 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
  • Flexible and able to use sound independent judgment and take initiative to assess information
  • Ability to demonstrate attention to detail
  • Able to make effective decisions in a fast-paced, highly dynamic environment

  • Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
  • At least 5 years' experience within a validation or compliance environment.
  • Experience of document authorship and control
  • Demonstrable experience of system validation processes
  • Demonstrable experience of working within organizations employing GAMP and GxP compliance
  • Contract Research Organization (CRO), Clinical or Medical experience
  • Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations

Desirable but not required:

ISEB/ISTQB Foundation certificate in Software testing