- 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 organisation 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;
- 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 (, 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).
- Experience working 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.
- Ability to travel expected at approximately 10%.
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Senior Clinical Quality Technology Specialist - Vélizy-Villacoublay, France - Dassault Systèmes
Description
About the Company:
Medidata: Powering Smarter Treatments and Healthier People
About the Team:
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.
Responsibilities:
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:
Qualifications:
Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata's non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides best-in-class benefits, including medical, dental, life and disability insurance; a generous pension; and 25+ paid holidays per year.
Applications will be accepted on an ongoing basis until the position is filled.
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