Be the next big change > Dassault Systèmes

Be the Next Game Changer

Senior Manager, Clinical Data Standards

United States, NY, New York Regular 6/29/2022 999008139

Medidata: Power Smarter Treatments and Healthier People

 

Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,900+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @medidata.

 

Your Mission:

 

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. 

 

Your Competencies:

  • 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.

Not available

Equal opportunity

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at 3DS are based on merit, qualifications and abilities. 3DS is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age (40 and above), disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. 3DS will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Covid statement

Our Company requires all U.S. employees to be fully vaccinated against COVID-19 and to provide documentation of full vaccination, unless qualified for a medical, religious or state-required accommodation or otherwise exempt 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 due to customer requirements, staffing needs, or other business reasons. Definition of full-vaccination: Employees are considered to be fully vaccinated two weeks after their second dose in a 2-dose series or two weeks after a single-dose vaccine.
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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.