Clinical Data Standards Manager

Medidata’s unified platform, pioneering analytics, and unrivaled expertise power the development of new therapies for over 1,000 pharmaceutical companies, biotech, medical device firms, academic medical centers and contract research organizations around the world. The Medidata Clinical Cloud® connects patients, physicians and life sciences professionals. Companies on the Medidata platform are individually and collaboratively reinventing the way research is done to create smarter, more precise treatments. For more information: www.mdsol.com.

We know that diverse teams win and are fully committed to selecting leaders and employees that represent the markets in which we operate. 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 2000 employees.

Your Commitments:

The Clinical Data Standards Manager is a key role on the Data Science team composed of statisticians, modelers, data developers, and business experts. We leverage industry leading data assets and analytical models to transform the clinical development industry, driving scientific and operational success for our clients and partners. We provide innovation-award-winning data-oriented products to most of the $100B pharmaceutical development industry. The Clinical Data Standards Manager will help drive the development and commercialization of new data-driven and cloud based analytics software products.

Your Competencies:

• Use deep knowledge of clinical data management standards and systems to discover and map data elements from raw clinical trials data files to internal standard data models and controlled terminologies to support construction of precision clinical analytics data assets and predictive models.
• Lead and/or conduct QC of work described above that is done by others.
• Understand and convert analytical data requirements to data collection domain/variables following internal data models and controlled terminologies.
• Use internal tools to review outputs of data standardization algorithms and automated statistical reports on multiple pooled trials, validating mappings and making recommendations to improve data quality and model performance.
• Work with statisticians, data scientists, programmers, and project managers to resolve clinical data definitions and meet customer project delivery deadlines.
• Perform ad hoc quality analyses on clinical trials data.
• Serve as knowledge and training resource to internal teams on eCRF designs, SDTM, and clinical data capture practices.

Your Education & Experience:

• BA/BS, Masters preferred, in a life science discipline.
• Minimum 10 years progressive experience at multiple companies in the pharmaceutical/CRO setting including depth in all the following:
  • SDTM creation
  • Clinical data manager or data standards manager
  • Participation in eCRF and EDC design
  • Clinical trials data collection and data QC processes
• Requires expert knowledge of Clinical Data Management, SDTM, and the creation of data mapping specifications.
• Knowledge of data structures within clinical data management systems.
• Basic working knowledge of SAS or SQL for data exploration.
• Strong documentation, communication and interpersonal skills.
• Prefer experience with phase 1-3 oncology trials.
• Prefer experience with Medidata Rave.
• Medical background is a plus.

Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development, enabling life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of most exciting areas for global innovation. Nine of the top 10 best-selling drugs in 2017 were developed on the Medidata platform.

Medidata’s solutions have powered over 14,000 clinical trials giving us the largest collection of clinical trial data in the world. With this asset, we pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of quality and efficiency to clinical trials enabling treatments to reach waiting patients sooner.

EEO Statement

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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