Clinical Systems Programmer II: EDC/CDISC Data Integrity

Pharmaron; Baltimore (MD); On-site; USD 60,000 - 70,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401(k) Retirement Plan with employer 4

Paid Time Off

Job summary

Pharmaron is seeking a Clinical Applications Programmer II to support configuration, programming, validation, and ongoing management of electronic systems used for clinical study data collection and analysis. You will work with cross-functional teams to ensure systems meet study requirements and industry standards.

The ideal candidate brings clinical research knowledge, EDC/eSource programming experience, CDISC familiarity, and 21 CFR Part 11 understanding.

Qualifications

• Bachelor’s degree/equivalency with 1 year of relevant experience in at least two areas: clinical research, eSource/EDC, application support, system validation/UAT, CDISC terminology
• High school diploma + 4 years of relevant experience in at least two areas OR 60+ college credits + 2 years in at least two areas
• Understanding of GCP and clinical research processes; CDISC standards and CDASH/SDTM concepts; ability to design data collection and reporting solutions; basic JavaScript proficiency

Responsibilities

• Configure eSource, EDC, Laboratory Information Systems and other clinical systems according to study docs
• Create CDISC/CDASH-compliant eCRFs, workflows, forms, and conditional logic
• Program screening, inpatient and follow-up workflows per study protocols
• Develop edit checks and data validation rules to ensure data quality
• Use JavaScript or similar to implement study-specific functionality
• Develop UAT documentation and support UAT activities
• Troubleshoot system issues and investigate defects
• Collaborate with cross-functional teams to ensure systems capture required data
• Support system upgrades, validations, and implementation timelines
• Maintain documentation for audit readiness and regulatory compliance

Skills

GCP understanding

CDISC standards

CDASH/SDTM concepts

JavaScript example

Data validation

Analytical thinking

Testing skills

Documentation

Regulatory compliance

Education

Bachelor's degree in life sciences/related field

Associate degree/equivalency

Master's degree in related field

Tools

Active Directory

SQL (MySQL/PostgreSQL/MS SQL/Oracle/Access)

Web technologies (JavaScript)

Job description

Pharmaron is seeking a Clinical Applications Programmer II to support configuration, programming, validation, and ongoing management of electronic systems used for clinical study data collection and analysis. You will work with cross-functional teams to ensure systems meet study requirements and industry standards.

The ideal candidate brings clinical research knowledge, EDC/eSource programming experience, CDISC familiarity, and 21 CFR Part 11 understanding.