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Data Standards Manager (Northern NJ - for Tier 1 Pharma Company)

Status: Contractor, 6 months with option to extend 12-18 months

A strong candidate should bring 7-10 years experience of diverse professional experience encompassing clinical research with focus in Data Management, business consulting, and system life cycle management with focus on Clinical Database Design.

This position will be the key driver/supporter in the development and maintenance of data standards across development. Co-lead the global standard governance committee and be responsible for metadata management, the management of Tier 1 Pharma Standard Data Dictionary and Global Laboratory Reference Data.

The main duties are:

As a Member of the Data Standards Governance Office

  • Co-lead the global standards governance committee
  • Responsible for the development of new standards and continued maintenance of existing standards
  • Consultant to Clinical Science Units teams, ensuring the enforcement of existing standards, key contributor to the development and implementation of new standards
  • As a data standards expert, analyze all new proposals/changes to existing standards.
  • Make a recommendation on new proposals/changes based on the overall impact on data, processes, & technology
  • Research and identify external standards through communication and education
  • Develop and maintain data standard governance policies and procedures
  • Develop and maintain data standards metrics to measure adherence to standards

Manage the Global Metadata Repository

  • As the metadata standards content expert, oversee the registration of new/changes to metadata
  • Provide guidance/best practices for metadata creation
  • Enforce metadata creation methodology and principles
  • Ensure no duplicates are created and definitions are complete and accurate

Manage the Tier 1 Pharma Standard Data Dictionary

  • Analyze all requests for accuracy and completeness
  • Enforce the use of existing standards wherever possible
  • Develop, maintain and follow the governance workflow and procedures
  • Consult with Clinical team members, assisting in the identification of existing standards and the development of new entities

Manage the Tier 1 Pharma Global Laboratory Reference Tables

  • Lead the Laboratory Reference Data Committee
  • Develop, maintain and follow the governance workflow and procedures for adding, changing or retiring laboratory reference data
  • Ensure medical accuracy and clinical meaningfulness for laboratory metadata
  • Identify and communicate to management any problems and impact regarding laboratory data
  • Consultant to Clinical teams, identifying existing reference data and evaluation of the need for new entries

Minimum Requirements

  • Strong knowledge of clinical data, as evident by 7-10 years diverse clinical research experience
  • Experience in design or management of clinical trial databases and/or metadata management
  • Advanced knowledge of drug development process. Must have good understanding of IT and how to apply standards to application provision
  • Needs strong analytical and communication skills
  • Ability to lead effective global teams
  • Spoken and written fluency in English
  • Role is 100% in Northern NJ

Octagon Research Solutions, Inc., is a fast growing Development Partnering Organization (DPO), which acts as a virtual partner in supporting its Biopharmaceutical & Pharmaceutical clients throughout the entire clinical research, development and submissions process. Based in Wayne, PA, Octagon meets their client's unmet needs by integrating information technology and multidisciplinary services to create a complete solution. We offer unparalleled practical knowledge and industry expertise that spans the clinical research and development lifecycle. Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.

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