Clinical Applications Programmer II

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

Position

Clinical Applications Programmer II

Salary Range

$60,000-70,000

Location

Baltimore, MD

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services. We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

What You'll Do

We are 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.

Key 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.

Required Qualifications

What We're Looking For

• 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

Knowledge & Skills

• 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.

Preferred Qualifications

• 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.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

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

As an Equal Employment Opportunity and Affidavit Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

About Pharmaron

Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

Pharmaron is proud to be an Equal Employment Opportunity and Affidavit Action employer.