Senior Lead Global Compliance & Strategy
Our Industry: Where we play
We sit at the intersection of technology and Life Sciences industries. Humbly, we’ve been told that we are the leader in application software for the clinical development process, tackling real-world problems and making a real difference in the lives of patients everywhere. With the current transformation in the life sciences industry, we are at the forefront of providing an advanced clinical development platform for our clients to further improve the accuracy, timeliness and ease of the data collection process. That means better treatments can reach waiting patients sooner. We are publicly traded (MDSO) with over 800 customers, customer retention rates above 99%, and the experience of supporting more than 12,000 clinical trials. We are still led by Co-founders, Tarek Sherif and Glen de Vries, and have global operations in US, Europe and Asia.
Enable both internal and external stakeholders to progressively enhance Medidata’s value proposition through the adoption of emerging clinical trial technologies while successfully meeting and navigating global regulatory expectations.
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.
• 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.
• Prior experience with a large central IRB or Ethics Committee is strong preferred.
Our Culture: Who we are
We know that creativity doesn't happen on-demand. Developing cutting-edge cloud technology takes great minds and talented people working together in a collaborative environment. That is why we are committed to fostering an innovative, agile company culture. We encourage our teams to come together and experiment with new concepts, research new approaches and test out new technologies. We believe that being part of our team will make a difference in the world.
Our Mission: Powering smarter treatments and healthier people.
Our Vision: To be the most innovative cloud company in Life Sciences.
Our Principles: Integrity, Partnership, Inventiveness, Humility, Nimbleness, Tenacity, Inclusiveness, and Caring.
Our Leadership Drivers:
• THINK: Inspires purpose, articulates strategy, and simplifies complexity
• TEAM: Communicates effectively, builds relationships and collaborates with others
• DO: Plans ahead, scales for growth, ensures accountability
• LEARN: Self-aware, values difference, strives to learn
• TEACH: Inspires work, coaches others, builds teams
Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.
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