Clinical Technology Compliance Analyst

United Kingdom, Hammersmith
Regular
12/8/2023
536426

Medidata: Power Smarter Treatments and Healthier People

Medidata, a Dassault Systèmes company, is leading the digital transformation of life sciences, creating hope for millions of people. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimise risk, and optimise outcomes. More than one million registered users across 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Known for its ground-breaking technological innovations, Medidata has supported more than 30,000 clinical trials and 9 million study participants. And Medidata’s ongoing commitment to infusing the patient voice into trial designs and solutions is helping to create a better and more inclusive experience for all participants in clinical studies. Medidata is involved in nearly 40% of company-initiated trial starts globally, with studies conducted in more than 140 countries. More than 70% of novel drugs approved by the Food and Drug Administration (FDA) in 2022 were developed with Medidata software. Medidata is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @medidata.

Your Mission:The Life Sciences industry is one of the most highly regulated industries, regulated to ensure the utmost patient safety, patient data security and patient privacy etc. Medidata has a leading- and cutting-edge Global Compliance and Strategy (GCS) department. Two core functions within GCS are excellence in quality management and compliance, and excellence in regulatory strategy.

Technology is unquestionably the most rapidly advancing aspect of modern life and the life sciences domain as a whole is one which with quality, intelligence and innovation can yield massive benefits for life sciences institutions and patients. This is evident with examples arising in the areas of precision medicine, technology-based biomarkers, the use of synthetic control arms, virtual human modelling and decentralisation of clinical trials, and the ability to apply ethical and trustworthy artificial intelligence to healthcare and research scenarios.
Reporting to the Senior Director of GCS EMEA based in the UK, the candidate will support the activities across GCS pertaining to quality management and regulatory strategy mainly for the EMEA region but also supporting other global GCS team initiatives. 


Quality ManagementAssociated activities around maintaining Medidata’s clinical quality management system in accordance with applicable regulations.Supporting Medidata’s customer assurance function with internal and external auditsAssisting in the analysis of quality incidents, supplier evaluations and root cause CAPA investigations. Contribute to the conduct of quality/process improvement initiatives in collaboration with cross-functional partners.


Regulatory StrategyProactively analysing the GCP regulatory environment and translating into impacts, to Medidata, our clients and patients and making interpretations that are communicable internally and externally. Supporting public consultations and responses to changes in guidance and legislation issued by Regulatory Authorities related to clinical trials international and regional, local, GCP, ICH GCP R3, data protection requirements, EU AI Act, new clinical diversity requirements, European Health Data Space, as examples.Interface and work collaboratively with trade associations, authorities and industry bodies on regulatory and technology initiatives to promote unity and foster industry working collaborations supporting the modernization and digital transformation of clinical trials. Helping to coordinate industry groups and supporting the Chair of the EUCROF New Technologies and ACRO Decentralised Clinical Trials industry Working Party Working in conjunction with Medidata marketing and other internal stakeholders to provide thought leadership through white papers and blogs.

Your Competencies:

  • Knowledge of Medidata and/or broader clinical technology systems is preferred, but not essential
  • Strategic thinking and analytical mindset
  • Ability to analyse and organise complex information
  • Ability to work in internal and external teams
  • Ability to work independently
  • Good presentation skills, and general confidence to contribute to leadership-level discussions.
  • Excellent written communication skills.


Your Education & Experience:

  • Bachelor's degree or equivalent years of experience; Master’s degree a plus.
  • Understanding the GxP-regulated environment within the Life Sciences domain is preferable.
  • Experience within clinical trial processes and technologies is preferable but not mandatory
  • An understanding of quality management systems enablement is preferable but not mandatory
  • Medidata systems experience a plus

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Diversity statement

As a game-changer in sustainable technology and innovation, Dassault Systèmes is striving to build more inclusive and diverse teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, it’s our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future.
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MEDIDATA generates the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes.