|Your Commitments: |
The ideal candidate will be able help shape the future of a Quality Management System in a Software as a Service (SaaS) technology company serving regulated companies.
With Medidata’s recent expansion into both electronic trial masterfile (eTMF) and electronic informed consent (eIC) offerings, the ideal candidate will serve as the primary champion and enabler to help foster adoption of these marquee capabilities as part of Medidata Clinical Cloud. The ideal candidate will also have secondary responsibilities to assist in other aspects of the Medidata Clinical Cloud including electronic data capture, Randomization and Trial Supply Management systems, among others.
Reporting directly to the VP, Global Compliance and Strategy, the ideal candidate will be responsible for interactions with other Medidata business units (e.g. Legal, Information Technology, Product Development), customers, and regulatory authorities on matters related to clinical regulations and data privacy. As Senior Lead Global Compliance & Strategy, you will have indirect reporting to Medidata’s Chief Privacy Counsel. ? Your Competencies:
• Solid working knowledge of the informed consent process (IC) with a strong understanding of risks and compliance challenges and how electronic informed consent (eIC) can address these areas without adding undue new unmitigated risks.
• Proven track record of working independently to evaluate requirements and propose solutions related to the informed consent process.
• Extensive experience in clinical trial processes and technologies, including, but not limited to a strong working knowledge of trial master file and site master files (TMF/SMF) and eTMF.
• Strong understanding of regulations governing clinical trials and privacy, including: o Clinical Regulations (e.g. EU Clinical Trial Directive / Regulation, FDA, etc.) o Privacy Regulations (EU GDPR, US HIPAA) o Frameworks guidelines including ICH Good Clinical Practices (GCP).
• Demonstrated experience as a compliance functional expert (especially with regards to clinical processes and technologies) with proven ability to present to corporate executives.
• Quality systems processes and enablement including auditing.
• Inspection management experience a strong plus. Your Education & Experience: • Bachelor's degree required with 12 years of experience, 8 years experience with a Master’s; or equivalent years of experience life sciences industry and/or medical/clinical operations.
• Requires a minimum of 3 to 5 years of experience in consent processes or informed consent / eTMF technologies.