- Enhance and promote Medidata's QMS and compliance approach as a Software as a Service (SaaS) technology company providing services to internal Medidata groups and regulated customers.
- Support key QMS functional responsibilities, not only related to issue management, but also including internal audits, vendor evaluation, documentation management, corrective action and preventive actions (CAPAs), reporting of issue management trends and metrics to GCS management.
- Collaborate with GCS peers in the performance and delivery of day-to-day activities of the GCS organization focused on customer requirements and the general needs of the business.
- Enhance Medidata's Trust and Transparency resources to further shape the direction of how we support our customers and partners.
- Bachelor's degree or equivalent years of experience; Master's degree a plus.
- Requires ~3 years experience in clinical trial processes and technologies, including a strong working knowledge of Quality Management Systems enablement, ideally in the area of continuous improvement initiatives and quality issue management.
- Technical knowledge of the Medidata systems and/or other clinical trial systems would be ideal along with a good understanding of computer systems validation.
- Strong understanding of regulations governing clinical trials including Clinical Regulations (e.g., EU Clinical Trial Directive / Regulation, FDA, etc.) and - Framework guidelines including ICH Good Clinical Practices (GCP).
- Experience as a compliance functional expert (especially with regards to clinical processes and technologies).
- Proven track record of working independently to evaluate requirements and propose solutions.
- Demonstrated experience as a compliance functional expert (especially with regards to clinical processes and technologies) with proven ability to present to corporate executives.
- Good presentation skills, and general confidence to contribute to leadership-level discussions.
- Excellent written communication skills.
- Ability to travel expected at approximately 10%.
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Senior Clinical Quality Technology Specialist - London, United Kingdom - Medidata Solutions
Description
This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.
Medidata: Powering 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, minimize risk, and optimize 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 and follow us @medidata.
About Medidata's Global Compliance and Strategy Group:
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 GCS department. Two core functions within GCS are excellence in quality and compliance, and excellence in regulatory strategy.
Medidata's GCS mission is to help its stakeholders successfully navigate and interpret the global regulatory landscape thereby enabling Medidata's clients to maximize the potential of the Medidata Cloud unified platform. The GCS team creates meaningful customer interactions through the application of a risk-based approach to continuously improving quality within the global clinical trial regulatory landscape.
Your Mission:
Oversight of Medidata's Quality Management System (QMS) and Customer Relationship Management is a key component of the GCS organization.
This role is focused on continuous improvement, as senior clinical quality technology specialist, you will be responsible for supporting and coordinating quality optimisation initiatives, such as quality incidents and general queries pertaining to quality management and regulatory aspects of the Medidata business.
To manage the coordination and execution of quality issue management related activities you will work closely with other colleagues within the GCS division such as customer assurance, vertical integration/quality processes and regulatory functions. You will interface regularly with Medidata's customers and will collaborate with Medidata internal customer facing business units such as Sales, Product, Legal, RFX, Professional Services.
you would report directly to the Senior Director, GCS EMEA, the ideal candidate will also:
Your Education & Experience:
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Diversity As a game-changer in sustainable technology and innovation, Medidata, Dassault Systèmes company, 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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