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Associate Director for Data Management

Cambridge, MA

Posted: 10/07/2019 Employment Type: Direct Hire Job Category: Clinical: Data Management Job Number: 2456

Job Description


Our client is seeking a high-performing, self-reliant, well-versed Associate Director for Data Management who can oversee the Data Management activities for all the studies within the company. S/he will be responsible for overseeing activity performed by Data Managers and vendors. The person in this role ensures execution of data management activity throughout client’ s study portfolio and will provide guidance and insight to the Data Management team and represent Data Management throughout the company.  Reporting to the Director for Biometrics (consisting of Biostatistics, Statistical Programming, and Data Management), the Associate Director Data Management will both perform and delegate tasks throughout a clinical study’ s lifecycle, schedule project deliverables, ensure consistent planning and execution within and across studies, anticipate internal business challenges and interact with departments throughout the organization.

Responsibilities:
  • Guide Data Managers through complex problems, building upon a portfolio of best practices.
  • Oversee all day-to-day data management activities, timelines and deliverables for client’ s portfolio of studies.
  • Provide technical and business expertise in support of data management deliverables.
  • Foster compliance with SOPs and Work Instructions.
  • Ensure timeliness and quality of data deliverables in collaboration with Biometrics department members, supporting vendors, and cross-functional colleagues
  • Build and refine models for resource forecasting and allocation.
  • Lead or contribute in process development, standardization, and technology initiatives.
  • Provide oversight of tasks performed by third-party vendors and data management CROs.
  • Establish strong relationships with data management vendors to enable optimal outcomes.

Requirements:
  • Bachelor’ s or Master' s degree in scientific, biological, statistical, computer science, or related field.
  • 10+ years of experience in clinical data management with can be augmented with experience in statistical programming or biostatistics.
  • Working knowledge of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines, CDISC data standards, and SDTM Good Clinical Data Management Practices (GCDMP) and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
  • Skilled in use of computer technology, including clinical trial databases and applications (Oracle Inform preferred), Coding Dictionaries (WHODrug, MedDRA). Knowledge and ability to use reporting tools (SAS programming and/or reporting tools) is preferred.
  • Excellent interpersonal and organizational skills with the ability to work independently, within teams, and leading or overseeing individuals or teams.
  • Excellent written and spoken communication skills.

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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