Clinical Informatics Specialist

MaximaTek; New York (NY); Presencial; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

MaximaTek is seeking a Clinical Informatics Specialist in New York to support collection, cleaning, integration, and governance of clinical data across EHR and EDC platforms.

You will bridge clinical operations, health IT, and analytics to optimize data quality, protocol compliance, and workflow efficiency across studies and healthcare systems. Collaboration with CRAs, data managers, and biostatisticians is essential.

Qualificações

• Bachelor’s or Master’s degree in a health/clinical informatics field is required.
• 0–5 years of experience in clinical informatics, clinical data management, health IT, or CRO environments.
• Strong analytical, clinical workflow, and data-driven problem-solving skills.
• Proficiency in SQL and database query writing.
• Hands-on experience with EHR/EDC systems (Epic/Cerner; Medidata Rave/REDCap).
• Knowledge of GCP, CDISC standards (SDTM/ADaM), HL7/FHIR, HIPAA, and regulatory guidelines.

Responsabilidades

• Review, clean, and validate clinical trial and health record data across EHR/EDC platforms.
• Participate in UAT, eCRF design, EHR workflow design, and data validation checks.
• Perform exploratory data analysis and generate dashboards using SQL, SAS, R, or Python.
• Ensure data collection and handling comply with GCP, CDISC, HL7/FHIR, HIPAA, FDA/EMA guidance.
• Collaborate with CRAs, Data Managers, IT, Biostatisticians, and Operations leads.

Conhecimentos

SQL proficiency

EHR/EDC systems

CDISC SDTM/ADaM

GCP knowledge

Data governance

Statistical programming basics

Communication skills

Formação académica

Health Informatics degree

Ferramentas

Epic/Cerner

Medidata Rave

REDCap

Oracle InForm

Descrição da oferta de emprego

About the Role: Clinical Informatics Specialist

We are seeking a detail-oriented and analytical Clinical Informatics Specialist to support the collection, management, cleaning, and integration of clinical trial and healthcare data. In this role, you will bridge the gap between clinical operations, healthcare technology, and data analytics to optimize data integrity, system usability, protocol compliance, and workflow efficiency across clinical studies and healthcare systems.

Core Responsibilities

• Clinical Data Management & Governance: Review, clean, and validate clinical trial and health record data across Electronic Health Record (EHR) and Electronic Data Capture (EDC) platforms. Identify data discrepancies, issue queries, and enforce data governance protocols.
• System Design & Workflow Optimization: Participate in User Acceptance Testing (UAT), electronic Case Report Form (eCRF) design, EHR workflow design, and the implementation of data validation checks aligned with clinical study protocols and operational workflows.
• Statistical & Informatics Support: Perform exploratory data analysis and generate routine summary reports, dashboards, and visualizations using tools like SQL, SAS, R, or Python to monitor study progress, data accuracy, and patient safety trends.
• Regulatory & Protocol Compliance: Ensure data collection, interoperability, and handling adhere to Good Clinical Practice (GCP), CDISC standards (SDTM/ADaM), HL7/FHIR, HIPAA, and regulatory guidelines (FDA/EMA).
• Cross-Functional Collaboration: Partner with Clinical Research Associates (CRAs), Data Managers, Healthcare IT teams, Biostatisticians, and Clinical Operations leads to ensure seamless system performance, timely database lock, and reliable data deliverables.

Qualifications

• Education: Bachelor’s or Master’s degree in Health Informatics, Nursing Informatics, Biostatistics, Data Science, Life Sciences, or a related quantitative/healthcare field (Required).
• Experience: 0–5 years of experience in clinical informatics, clinical data management, healthcare analytics, health IT, or CRO environments.
• Required Skills:
• Strong analytical, clinical workflow, and data-driven problem-solving skills.
• Proficiency in SQL and database query writing.
• Hands-on experience with Electronic Health Record (EHR) systems (e.g., Epic, Cerner) and/or Electronic Data Capture (EDC) systems (e.g., Medidata Rave, REDCap, Oracle InForm).
• In-depth knowledge of clinical processes, health informatics concepts, medical terminology, and GCP standards.
• Excellent written and verbal communication skills for cross-functional reporting and stakeholder training.
• Preferred Skills:
• Familiarity with statistical programming languages (SAS, R, or Python) and data visualization tools (Tableau, Power BI).
• Knowledge of CDISC data standards (SDTM/ADaM) and healthcare interoperability standards (HL7/FHIR).
• Basic understanding of clinical database programming or system validation logic.

What We Offer

• Targeted Placement: Direct marketing to our network of hiring managers in the MedTech, Biotech, Pharmaceutical, and Healthcare Provider industries.
• Technical Resume Rebuild: Optimization of your profile to highlight clinical informatics, health data analytics, and regulatory compliance metrics.
• Interview Coaching: Guidance on technical clinical informatics case studies, SQL/analytical assessments, and clinical systems management interviews.

Ready to Take the Next Step?