Clinical Applications Programmer II

Pharmaron • Baltimore, MD

2d • Onsite

About The Position

Pharmaron is seeking a Clinical Systems Programmer II to support the configuration, programming, validation, and ongoing management of electronic systems used to collect, process, and analyze clinical study data. This role will work closely with Clinical Data Management, Clinical Operations, Laboratory, IT, Regulatory, project teams, and study sponsors to ensure clinical systems are designed, tested, documented, and maintained in accordance with study requirements and industry standards. The ideal candidate combines clinical research knowledge, EDC/eSource programming experience, clinical database design, and familiarity with CDISC standards and 21 CFR Part 11 requirements. This is a hands-on role for someone who enjoys solving complex system and data challenges while ensuring high-quality, compliant clinical data collection.

Requirements

• High school diploma plus 4 years of relevant experience in at least two of the following areas; OR Associate degree/equivalency (60+ college credit hours) plus 2 years of relevant experience in at least two of the following areas; OR Bachelor's degree/equivalency (120+ college credit hours) plus 1 year of relevant experience in at least two of the following areas:
• Clinical research, life sciences, public health, or related field
• eSource or EDC study design and configuration
• Application support
• System validation and User Acceptance Testing
• CDISC terminology and standards
• JavaScript or other programming languages
• Understanding of Good Clinical Practice (GCP) and clinical research processes.
• Working knowledge of CDISC standards, including CDASH and SDTM concepts.
• Experience designing data collection solutions that support standardized clinical trial data capture and reporting.
• Basic proficiency with JavaScript or a similar programming language.
• Strong analytical and critical-thinking skills with the ability to troubleshoot complex system and data issues.
• Strong quality-control and testing skills.
• Ability to analyze system requirements and evaluate how system changes may impact clinical study operations and data.
• Excellent communication and active-listening skills.
• Ability to manage multiple priorities and meet programming and testing deadlines.
• Ability to work independently and collaboratively across functional teams.
• Strong attention to detail and commitment to data quality and regulatory compliance.

Nice To Haves

• Master's degree in Computer Science, Health Informatics, Clinical Research, Data Science, or a related field.
• Industry certifications in clinical research, data management, EDC systems, programming, or related disciplines.
• Experience with Active Directory administration.
• Network troubleshooting experience.
• Application support experience.
• Laboratory, pharmacy, or clinical application experience.
• Web design, programming, and/or web administration experience.
• Experience with MySQL, PostgreSQL, Microsoft SQL, Oracle, and/or Microsoft Access.
• Laboratory, pharmacy, or clinical management experience.

Responsibilities

• Configure eSource, EDC, Laboratory Information Systems, and other clinical systems based on study protocols, laboratory manuals, pharmacy manuals, and related study documentation.
• Create and maintain CDISC/CDASH-compliant eCRFs, study workflows, dynamic forms, and conditional logic.
• Program screening, inpatient, and follow-up workflows in accordance with study protocols and source templates.
• Develop and maintain edit checks and data validation rules using logic operators to authenticate data entered into electronic forms.
• Utilize basic JavaScript or similar programming languages to create and modify methods, edit checks, and study-specific functionality.
• Develop User Acceptance Testing (UAT) documentation and support Clinical Information Specialists in completing UAT activities.
• Troubleshoot system issues, investigate defects, and implement appropriate solutions.
• Participate in meetings with Project Managers, clinical and laboratory leaders, and study sponsors to ensure systems capture, process, and report required study data.
• Collaborate with Clinical Systems leadership, IT, and Regulatory teams on system upgrades, implementation timelines, and validation activities.
• Assist with the development of templates, SOPs, training materials, and standardized practices to improve efficiency and minimize study-specific build time.
• Meet established programming, testing, and study implementation deadlines.
• Maintain comprehensive documentation to support audit readiness and regulatory compliance.
• Provide system training and ongoing technical support to subject matter experts and end users.
• Serve as the primary systems point of contact for assigned clinical studies.
• Work independently while collaborating effectively with the Data Management team and cross-functional stakeholders.
• Support compliance with Good Clinical Practice (GCP), CDISC standards, 21 CFR Part 11, and applicable clinical research requirements.

Benefits

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
• 401(k) Retirement Plan with generous employer matching
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
• Employee Assistance Program (EAP), mental health resources, and wellness programs
• Family-friendly benefits, including fertility support and maternity resources
• Professional development and career growth opportunities within a leading global CRO/CDMO

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED