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.
As the Senior Global Compliance and Strategy lead, you will be responsible for helping us shape the future of our Quality Management system, as we continue to work in a regulated landscape. You will enable both internal and external stakeholders, to progressively enhance Medidata’s value proposition through the adoption of emerging clinical trial technologies, while successfully navigating global regulatory expectations.
With Medidata’s recent expansion into both electronic trial master file (eTMF) and electronic informed consent (eIC) services, you will be the primary champion, and advocate, to help foster adoption of these capabilities – and support other aspects of our Clinical Cloud, including Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM), among others.
Reporting directly to the VP, Global Compliance and Strategy, you will be interfacing with, and responsible for interactions with other Medidata business units (e.g. Legal, Information Technology, Product Development), customers, and regulatory bodies on matters related to clinical regulations, directives and guidances as well and data privacy and confidentiality matters.
- You have a proven track record of working independently and in conjunction with internal and external stakeholders to understand and evaluate requirements and propose solutions.
- Extensive experience in clinical trial processes and technologies is preferred, including, but not limited to a strong working knowledge of trial master file and site master files (TMF/SMF.)
- Strong understanding of and experience with international regulations, directives and guidance’s, governing clinical trials and privacy/confidentiality, including -
- Clinical regulations (e.g. EU Clinical Trial Regulation, ICH E6(R2))
- Privacy Regulations (e.g. EU GDPR, US HIPAA).
- You are a compliance functional expert (especially with regard to clinical processes and technologies) and able to influence senior stakeholders and corporate executives.
- Strong knowledge and experience of Quality Management Systems including, in particular, software development/validation and related processes.
- You have experience in inspections from regulatory agencies and audits by customers, and in conducting internal audits and due-diligence on external service providers.
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 7-10 years of experience serving the life-sciences industry.
- Experience with clinical trial research strongly preferred.in
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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