Senior Clinical Data Standards Specialist - Technology GTD at Signant Health

Role Purpose:

The purpose of the role is two parts: first to ensure clinical study data is collected, transformed, and validated to industry and customer data standards, ensuring high-quality data is delivered to customers for statistical analysis, within agreed upon project timelines. And second to provide input to internal departments as the SME and to build and maintain Signant’s global data standards.

Key Accountabilities

• Lead and participate in the development and maintenance of Signant Health’s global clinical data standards, including CRF CDISC Study Data Tabulation Model (SDTM), controlled terminology, and other applicable industry and customer standards
• Participate in relevant team meetings as SME for standards and provide input for data standards to customers and internal stakeholders (Business Development, Medical/Clinician, Product, R&D, etc.), such as eCRF design, data transfer specifications, SDTM mapping, edit checks, etc.
• Work with and participate in the implementation of a Clinical Data Management System (CDMS), which may include the development of a clinical metadata repository, and data validation checks
• Design and maintain discrepancy management system
• Author core data management templates: Data Management Plan (DMP), Data Transfer Specifications (DTS) and Data Review Plan (DRP)
• Participate in regulatory agency and internal audits as necessary

Decision Making and Influence:

The Sr CDSS will lead discussions related to industry guidelines and clinical data management solutions and have a key role in standardizing and driving the adoption of clinical data management processes, implementation of best practices and the use of clinical data management systems to improve quality and streamline data collection and validation efforts. The Sr CDSS will help establish the Signant Health data governance and standards committee and maintain regular cadence with customer’s standard team.

Knowledge, Skills Attributes:

Essential

• Bachelor’s degree or equivalent required in Health or Science discipline with experience in clinical research
• 7 + Years of data management experience in CRO, pharmaceutical, biotechnology, or medical device industry
• 5+ years in a client-facing, leading data management role
• In depth knowledge and experience in CDISC standards especially in the collection (CDASH) and tabulation (SDTM) models
• Experience with Clinical Data Management Systems (CDMS)
• Operational understanding of data storage model requirements and formatting for data transfers
• Demonstrate entrepreneurial (proactive) mindset with high energy and personal drive
• Experience leading and driving cross functional initiatives, demonstrating good project management skills
• Highly organized and focused, with effective written and verbal communication, teaching, and presentation skills
• Ability to problem-solve with specialists and condense content to effectively present to senior leaders

Desirable

• Strong Microsoft Office skills for presenting and reporting (Excel, Word, PowerPoint, etc.)
• The ability to query and analyze data using SQL, Python or R