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Data Standards Consultant, Biopharma - Remote (JP10253)

Raleigh, NC · Biotech/Pharmaceutical
Job Title: Data Standards Consultant, Biopharma - Remote (JP10253)
Location: 
Raleigh, NC. 27513 (Remote)
Employment Type: Contract
Business Unit: 
Global Biostatistical Sciences - Biomedical Data Stewardship (BMDS)
Duration: 3 years with possible conversion to FTE
Notes: 100% Remote
Posting Date:  05/12/2022

3 Key Consulting is hiring Data Standards Consultant for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

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 company 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.
     
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)
     
Top Must-Have Skill Sets:
Key Skills / Knowledge:
  • In-depth knowledge/experience of data collection, analysis, and reporting in drug development and clinical trials processes **IS A MUST**
  • Collaborating in global 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.

Employee Value Proposition:
Unique lab setting. Opportunity

Red Flags:
This candidate should possess all of the qualifications above (please review the job description in total detail).
This candidate should be diplomatic and have strong communication and collaboration skills with ability to take initiative in their own and teams work

Interview process:
Interview with hiring manager (1 hour) then panel interview with team (1 hour)

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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