Clinical Data Specialist

Hartford, CT, US • Posted 16 hours ago • Updated 3 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Reporting
Unstructured Data
Testing
Data Validation
Data Quality
Data Modeling
Machine Learning (ML)
Forms
Data Processing
Workflow
Conflict Resolution
Problem Solving
Auditing
Documentation
Science
Health Care
Research
Medical Devices
Biomedicine
Informatics
Biostatistics
Pharmaceutical Industry
CDISC
MedDRA
Database
Data Management
Clinical Research
Product Development
Clinical Trials
Information Governance
Google Cloud Platform
Google Cloud
Clinical Data Management
21 CFR Part 11
HIPAA
Project Management
Analytical Skill
Communication
Management
Marketing

Summary

Responsibilities:

Reporting to the Clinical Data Manager, you'll be responsible for the development of real-world data variables from structured and unstructured data sources, including designing data capture forms and supplemental procedures to instruct the abstraction process
You'll lead the execution of feasibility testing to de-risk data capture approaches, and own the implementation of data validation checks to ensure data quality
In addition, you'll work alongside other team members on ways to improve data models
Manage, maintain, and serve as clinical data expert for a portfolio of real-world data deliverables
Plan and execute real-world data management activities through the lifecycle of a product, including data model development, data processing methods (e.g., abstraction, structured, machine learning, etc.), design of data capture forms and associated instructions, creation of quality check logic, analysis of controls for efficiency and effectiveness, and development of quality check resolution guidance
Surface opportunities for product enhancements by leveraging feedback channels, including but not limited to client requests, clinical landscape developments, industry trends, regulations, and/or data processing challenges
Plan and execute feasibility experiments for variable development, applying insights to align and recommend optimal variable design, data source(s), efficiency, quality, and production cost
Contribute to the development and maintenance of internal and external real-world data variable user guidance
Identify opportunities for improvement in processes/workflows, contribute to problem-solving discussions with stakeholders, and support the design and implementation of solutions, including but not limited to tooling, templates, or modifications to software platforms
Maintain audit-readiness of documentation through conformance to procedures and applicable data standards.

Requirements:

Bachelor's or master's degree in science or healthcare related field, or equivalent practical experience
In addition, you have 2+ years of experience working in clinical data management, clinical or lab research, and/or related work experience in a medical device or pharmaceutical industry/company
You have an advanced degree in biomedical science, informatics, biostatistics, or relevant experience
ware of pharmaceutical industry health data standards such as CDISC and MedDRA
Passionate and collaborative problem-solver who values the opportunity to think beyond the way things are
Experience navigating clinical databases such as EDCs, EMRs, or other data management systems
Familiar with clinical research and medical product development, clinical trial processes and related regulatory requirements or information governance frameworks (e.g ICH Google Cloud Platform, Good Clinical Data Management Practices, 21CFR11, HIPAA)
Strong project management, organizational, analytical, and written and verbal communication skills
Self-motivator who is able to identify problems and propose solutions in a highly dynamic and fast-paced environment
Experience managing data for real-world evidence programs, registries, or other post-marketing studies

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: bcd33291b8fd59fac0dcff10ffde5dc5
Posted 16 hours ago

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Clinical Data Specialist

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