Data Standard Consultant

Company: TechTrueUp
Location: Raleigh
Posted on: May 15, 2022

Job Description:

Job DescriptionDescription:100% remote

Title: Data Standards Consultant

Department: Global Biostatistical Sciences - Biomedical Data Stewardship (BMDS)

Reports to: Director, Biomedical Data Stewardship

Responsibilities: Designing, defining, and reviewing data quality edit checks for inclusion in data standards and in consultation with study teams for study-level implementation Developing and maintaining processes for the design and implementation of data quality edit checks Manage data standards collection components (forms, fields, controlled terminology (i.e., codelists), edit checks, derivations) in a metadata repository (MDR) Participate in the definition and maintenance of data standards collection components Review/audit study-levKey Skills / Knowledge: In-depth knowledge/experience of data collection, analysis, and reporting in drug development and clinical trials processes Collaborating in global crel deliverables for compliance to data standards Develop and compile metrics for communicating outcomes of data standard compliance reviews/audits Provide additional support to study teams on the adoption of data standards Drive and facilitate the expansion of data standards across Our Client Global Development

Cross-functional teams Experience in project management, documentation writing, training, and compliance Interest in process improvement methodologies Use of software and data applications within drug development Appreciation of computer system architecture and hardware Experience with metadata repositories not necessary, but must have a willingness to learn the metadata repository application and underlying data tables and be comfortable extracting data from databases for reporting.

Qualifications: Basic Qualifications Bachelor's degree or equivalent in statistics/ biostatistics, programming, life science, computer science, business administration or related discipline or equivalent combination of education and experience. 8+ years knowledge/experience in Pharmaceutical / Biotech industry Demonstrated effective communication skills (written and oral)

Preferred Qualifications Bachelor's degree or Master's degree, in statistics/ biostatistics, programming, life science, computer science, business administration or related discipline

10 or more years cumulative work experience in data management, biostatistics or programming in Pharmaceutical or Biotechnology companies

3 or more years of experience in a global organization

Ability to influence decision making

Project planning and management

Process improvement leadership

Participation in the development of policies and SOPs

Effective communication skills (written and oral)

Keywords: TechTrueUp, Raleigh , Data Standard Consultant, Professions , Raleigh, North Carolina