Director, Head of Data Management

Job Description

Organization: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 241021
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%

Job Description:

Position Title: Director, Head of Data Management

This position will be responsible for coordination, execution and communication of Data Management activities within the Quality organization of Laboratory Diagnostics. The Head of Data Management oversees and directs a team of data managers and database developers assigned to clinical evaluations of in vitro diagnostic devices. This role drives development of innovative solutions in data management activities and electronic data collection from complex, diverse sources and ensures timely delivery of high quality data in a highly regulated and changing global clinical trial environment. This position resides in Tarrytown, NY. This position fits in the SHS DX LD QT MBDQ organization as Director, with management of direct reports as well as individual contribution expectations. The position will report into the VP and Global Head of Medical, Biostatistical and Design Quality.

Responsibilities
  • Executes data management activities for analytical and clinical performance studies in pre- and post-market settings. May also act as technical lead or provide oversight to projects involving Quality, Regulatory Affairs, and Information Technology

  • Directs resources and timeliness to ensure data management deliverables meet defined business milestones. Pro-actively identifies challenges/risks and identifies mitigation and contingency plans accordingly. Provides updates to cross-function teams and Quality management regarding ongoing data management activities

  • Drives partnerships with Assay Development, Clinical Affairs, and Pre-Market Biostatistics on study design, eCRF design, data management planning and contribute to clinical plans, protocols, and study reports

  • Develops, executes, and maintains Data Management Plan (DMP) throughout project lifecycle

  • Integrates guidance and training to team over all phases of EDC development (including eCRF design, user requirements, edit rules/checks, and query logic, CRF completion guidelines), validation (UAT), study close-out, and archiving

  • Drives data quality monitoring during execution of study and pro-actively work with team to resolve queries and address changes to EDC as a result of deviations or protocol changes

  • Develops vendor relationships (when applicable) related to data management resourcing, services and systems. Coordinates and contributes to the establishment and execution of contracts, purchase orders (POs), and Service Level Agreements (SLAs)

  • Responsible for developing and maintaining SOPs related to the data management process and data management systems

  • Ensures compliance to data management processes and change management within EDC for query resolution, lock/unlock/relock processes and for data snapshots required for interim analyses

  • Performs close-out audit, as specified, for closing of study trial in EDC or other clinical data management systems.

    Required Knowledge/Skills, Education, and Experience

 
  • Bachelor’s degree, with preferred areas of study in biological science, computer science, data science, or engineering

  • At least 10 years of data management experience and/or clinical  experience in the medical device, medical diagnostics or pharmaceutical industry with progressive job responsibilities

  • Substantial knowledge and experience in data management processes and experience with one or more EDC systems. Preferred candidate will have experience with Medidata RAVE EDC system

  • Experience with software and systems to support clinical trial processes such as CTMS, ETMF, and Clinical MDR. Additional experience in supporting implementation and validation of systems is a plus

  • Knowledge of data standards, such as CDISC / CDASH and STDM models, and medical coding (MEDRA, WHO DRUG) is desirable

  • Experience with vendor management, including coordinating contracts, POs, and SLAs with vendors of data management systems and external consultants/staffing/CROs supporting data management activities

  • Working knowledge of Good Clinical Data Management Practices, Good Clinical Practices, clinical research, clinical trial process and related regulatory requirements and terminology

  • Strong interpersonal, organizational, and communication skills

  • Proven ability to develop team members through mentoring and coaching in complex subjects

  • Collaborative, cross-functional consensus builder with a strong sense of self that enables one to be confident in his/her convictions, even if not commonly shared, with the ability to inspire alignment and commitment from others

 

   

 

 

 


 

 

   

  


     

 

 

 

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