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Reporting to the Director, Clinical Data Standards, you will provide leadership to achieve the strategic roadmap for industrialized standardization of historical clinical trial data using industry standards (e.g., CDASH, SDTM, ADaM) and related processes. Working collaboratively with internal and external organizational leads you will provide high-quality, regulatory-compliant standardized data to improve clinical trials. The Sr Manager will support development of technical expertise and documentation for data standardization activities and will help implement proprietary algorithmic data standardization models.
Lead team of clinical standards subject matter experts, focusing on the application and maintenance of industry standards (CDASH, SDTM, ADaM) to create regulatory grade integrated historical clinical trial data sets.
Provide expert support for regulatory inspections with knowledge of industry regulations, legal mandates, processes, and business policies
Develop quality system documents (SOPs, WIs) to ensure accuracy, compliance and traceability of standardized clinical trial data
Improve processes for industrialized clinical data standardization, including implementation of proprietary algorithmic data standardization models
Collaborate with Biostatisticians, Product and Project Management to set project goals, provide standardized data for analysis and prepare for regulatory inspections
Your Education & Experience:
7+ years of clinical standards (SDTM) and data management experience in pharma/biotech with advanced knowledge in clinical trials including design, specification, QC and submission preparation.
3+ years of supervisory and mentoring experience using a hands-on management approach
Expert experience in clinical standards (e.g., CDASH, SDTM, ADaM), including development and management of metadata repositories
Master's degree or equivalent preferred, in a life science discipline or Biostatistics
Detailed knowledge of FDA & ICH, GCP, and regulatory submission requirements (e.g. define.xml, ISS, ISE, CFR-Part 11 compliance)
Experience participating in and responding to audits and regulatory authority inspections
Working knowledge of SAS (including macro development) and SQL for data preparation and exploration; R and python are a plus
Medidata requires all U.S. employees to be fully vaccinated against COVID-19 and to provide documentation of full vaccination, unless qualified for an accommodation as determined by Medidata, consistent with applicable law. Although accommodation requests will be considered (and granted where appropriate/possible), it may be determined that a candidate is unable to adequately perform the essential functions of the position without imposing an undue hardship on Medidata due to customer requirements, staffing needs, or other business reasons.
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.
MEDIDATA generates the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes.