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Senior Standards Validation Lead

Plats Warszawa, Masoviens vojvodskap, Polen Gaithersburg, Maryland, USA Cambridge, England, Storbritannien Jobb-id R-101319 Datum inlagd 02/25/2021

The Senior Standards Validation Lead is a member of Clinical Data Standards team, primarily responsible for leading the validation process in RAVE system including all technical activities in their area of expertise with quality and timeliness, also being able to establish new methodologies and processes. This position requires high technical skills and excellent industry knowledge to lead and perform the validation related tasks. Acts as subject matter expert and may manage external partner relationships or initiatives. May provide training or coaching to other colleagues.

Typical Accountabilities

  • Coordinates life cycle management and business continuity for RAVE Standards Library validation processes, systems/tools, standards, procedural documentation and training materials
  • Defines and develops User Requirement Specifications and User Acceptance Tests
  • Delivers validation activities and documentation for RAVE Standards Library collection and cleaning components
  • Performs independent Quality control of RAVE validation documents
  • Can plan and lead team activities and tasks for RAVE validation deliverables
  • Leads quality of own deliverables and oversees quality of other developers for RAVE validation deliverables
  • Contributes to the development of best practices for RAVE Standards Library validation
  • Provides expert support within Clinical Data Standards Team on RAVE Standards Library validation process
  • Can manage activities of our external Partners
  • Subject matter expert in RAVE Standards Library validation deliverables

Essential

  • University degree in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience.
  • Experience in Validation of computerized systems in a regulated environment, preferably the Pharmaceutical industry (e.g. RAVE EDC system), including familiarity with documentation such as Validation Plans, Reports, Test scripts etc. and knowledge of regulatory (GxP, etc.) requirements for computerized systems and infrastructure or accomplished experience in Data Management
  • Experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment
  • Knowledge of MS Excel, deep attention to the details and a systematic approach to work
  • Good knowledge of the clinical development process
  • Good project management skills
  • Excellent  communication skills in both written and spoken English
  • A clear demonstration of behaviours of truth seeking rather than success seeking
  • Embracing peer review

Desirable

  • Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement
  • Ability to proactively manage concurrent activities within role
  • Experience in the development and management of Business Process to deliver business performance



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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