Clinical Data Content Manager
Our Industry: Where we play
Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development. Our work ensures that life-saving drugs and medical devices get to market faster. We are a certified “Great Place to Work” with highly engaged employees focused on improving the health outcomes of patients across the globe.
We develop cloud-based enterprise products and services and are a world leader driving the convergence of the Technology and Life Sciences industries, one of the most exciting areas for innovation globally. With annual revenue in 2016 of nearly $500 million, we are publicly traded (MDSO) with over 850 customers and customer retention rates above 99%. The Medidata Clinical Cloud® is the primary technology solution powering clinical trials for 18 of the world's top 25 global pharmaceutical companies and is used by 18 of the top 25 medical device developers—from study design and planning through execution, management and reporting. Our customers include global pharmaceutical companies, biotech, diagnostic and device firms, leading academic medical centers, technical partners and contract research organizations.
By automating over 12,000 clinical trials to date, Medidata has the largest collection of clinical trial data in the world. Today, Medidata pioneers innovative, advanced applications and intelligent data analytics, bringing a new level of quality and efficiency to clinical trials. That means better treatments reach waiting patients sooner.
We know that diverse teams win. It is our diversity and inclusiveness that fuels innovation and sparks our passion and commitment to patient health. We are still led by our Co-founders, Tarek Sherif and Glen de Vries, and have global operations in US, Europe and Asia with over 1900 employees.
The individual will utilize his/her deep experience with clinical trials subject data and sharp analytic skills to support the creation of precision datasets powering a new suite of clinical analytics customer products which leverage Medidata’s store of thousands of clinical trials.
- Use deep clinical/EDC data knowledge to discover and map data elements in raw clinical trials data files to support construction of precision clinical analytics datasets.
- Research and classify clinical trials by searching and reviewing wide-ranging qualitative sources such as clinicaltrials.gov, PubMed, and disease references.
- Review outputs of data standardization algorithms and statistical reports on thousands of pooled trials, validating to sources and clinical norms to make recommendations.
- Use analytic programming tools (SAS or R, in house) against clinical trials datasets to do exploratory data analysis.
- Contribute to teams developing generalized algorithm logic for standardizing data across thousands of clinical trials.
- Document and summarize analysis results for statisticians, data engineers, and project managers.
- Run, review, publish, and support automated data summaries.
- Serve as knowledge and training resource to team on SDTM and other clinical data standards.
Your Education & Experience:
- Master’s degree in life science or a quantitative discipline required.
- Minimum 8 years experience, 5 years working with subject data from many clinical trials including hands-on work in, and deep knowledge of, all of the following:
- Clinical trials data collection design and process (eCRF, EDC)
- Analysis of subject-level clinical trials data from EDC systems
- Writing SDTM programming specifications
- Data quality methods
- Requires intermediate skills in SAS or R (and light SQL) for data exploration.
- Ability to explore clinical datasets and complex scientific documents and make sophisticated judgments about meaning of, and patterns in, data.
- Working knowledge of CDISC/SDTM required.
- Prefer work experience at multiple pharmaceutical research companies.
- Prefer experience with phase 1-3 oncology trials.
- Prefer experience with Medidata Rave.
- Strong documentation, communication and interpersonal skills.
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
US: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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