Implementation Consultant

Our client is growing at pace due to the success of their Industry leading products for clinical trials.

Pop Science are working in Partnership exclusively looking for an Industry leading Implementation Consultant (office based in Cambridge) that wants to apply knowledge and experience to the creation of a leading edge web application for the clinical trials industry. 

We are looking for a dynamic and driven individual, who wants to apply knowledge, experience and vision in the development of validation processes for a leading cloud-based platform for the clinical trials industry.

You will be working on their product, which is continually growing and evolving to address the needs and requirements of the Industry.

This role will play a significant part in the growth and development of the product validation team, including defining and implementing the validation tool chain to support Agile development and automated testing.

In the clinical trials industry, validation of products that are used to inform decisions on patient safety and well-being and data quality and integrity is of the utmost importance.

This role will be responsible for the overall quality of the product, working closely with the  Product Owner and Dev-Ops team.

They are passionate about theirr culture and values and we are looking for someone who will thrive in a hardworking, energetic, creative and team-oriented environment. 

YOU MUST HAVE LIFE SCIENCE  INDUSTRY EXPERIENCE and you will be excited by the opportunity to have a leading role in the defining processes and building a team that will be responsible for the quality of the product.

This role will have direct access to the senior leadership team, and the opportunity to be involved in the creation of an application that will truly make a difference to advancements in getting medical treatments to patients.

Location: the United Kingdom, Cambridge (Sorry no Sponsorship available)

You should recognise yourself here:

Minimum of four years of relevant validation experience

•          Self-motivated

•          Enjoy working in a small results-oriented team

•          Ability to evaluate functional and technical specifications for risk to validation and product quality

•          Ability to turn product specifications into detailed validation plans and on to reliable, high quality product releases

•          Ability to take responsibility for the consistency and quality of all deliverables

•          Ability to mentor validation engineers

Technical Experience 

•   Must already have  Good working knowledge of industry standards for software development and validation i.e. ISO/IEC 9003: 2004, Software Engineers - Guidelines for the application of ISO 9001:2000 to computer software; ICH E6, GaMP5, HIPAA 1996, HIPAA Privacy and Security Rules 2003, FDA Regulation 21 CFR Part 11, FDA Guidance for Industry on Computer Systems used in Clinical Investigations, FDA General Principles for Software Validation, EudraLex Volume 4 Annex 11: Computerized Systems.

•          Implementation and use of automated test software

•          Knowledge of validation of computer simulation models would be an advantage

You will be responsible for:

•          Creating the validation processes for the next evolution of the product which will include changes to the development toolchain

•          Working with the Product Manager and Development Lead to understand the development tool chain and select and implement the validation tool chain, including automated testing, that will best support the development methodology

•          Working with Dev-Ops to plan validation activities for each release, the release schedule for 2019-20 is aggressive and getting the right tool chain and processes in place is critical

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