EDC Programmer

Key Responsibilities

• Design and build Medidata Rave studies from the ground up across Phase I, II, and III clinical trials, including eCRF design, edit check programming, and study configuration.
• Develop custom functions in Rave to address complex data validation logic, derived fields, and conditional branching beyond standard edit check capabilities.
• Configure and maintain Rave study components including forms, fields, matrices, data dictionaries, derivations, and custom edit checks using Rave Designer and Architect.
• Collaborate with CDM, Biostatistics, and Clinical Science teams to translate protocol requirements and CRF specifications into technically sound EDC database designs.
• Develop and review Database Design Documents (DBDs), CRF Completion Guidelines, Edit Check Specifications, and User Acceptance Testing (UAT) plans.
• Lead UAT activities, including authoring test scripts, executing tests, documenting defects, and driving resolution with vendors and internal stakeholders.
• Manage study amendments and database changes throughout the trial lifecycle, maintaining thorough documentation of all modifications in accordance with SOPs and regulatory requirements.
• Oversee and coordinate EDC-related activities with CROs and external vendors, providing technical guidance and ensuring deliverable quality and timeline adherence.
• Ensure compliance with CDISC/CDASH standards in EDC database design, supporting downstream SDTM mapping and data review efforts.
• Build and configure Medidata Rave RTSM modules, including randomization schemes, stratification factors, depot/kit management, and resupply algorithms.
• Manage integrations with third-party RTSM/IRT systems (e.g., 4G Clinical, Suvoda, YPrime, Veeva Vault RTSM), including specification development, interface testing, and ongoing operational support.
• Support data migration, external data loads (lab, ePRO, ECG, etc.), and integration with other clinical systems as needed.
• Contribute to the development and continuous improvement of EDC standards, templates, and best practices to support a scalable, growing clinical portfolio.
• Participate in study team meetings, providing EDC-related updates, risk assessments, and timelines.

Requirements

• Bachelor’s degree in Life Sciences, Computer Science, Information Systems, or a related field.
• Minimum 4+ years of hands-on experience as an EDC Programmer or Database Designer in a clinical trial environment.
• Expert-level proficiency with Medidata Rave, including Rave Designer, Rave Architect, and Rave Studio; Rave certification preferred.
• Demonstrated experience building clinical trial databases across Phase I, II, and III studies, including first-in-human (FIH) through late-phase pivotal trials.
• Strong custom function development experience in Medidata Rave, including complex validation logic, multi-field derivations, and dynamic form behavior.
• Solid understanding of CDISC/CDASH standards and their application to eCRF design and data collection.
• Experience with the full EDC lifecycle: requirements gathering, database build, UAT, go-live, amendments, database lock, and archival.
• Familiarity with MedDRA and WHO Drug Dictionary coding and integration with Rave.
• Knowledge of clinical trial processes, ICH E6 GCP guidelines, and regulatory requirements (FDA, EMA).
• Experience working with CROs and managing external vendor relationships in an EDC context.
• Strong attention to detail and a track record of producing high-quality database builds with minimal rework.
• Excellent written and verbal communication skills with the ability to translate technical concepts for non-technical stakeholders.
• Ability to manage multiple studies simultaneously in a fast-paced, agile environment.
• Hands-on experience building Rave RTSM studies, including randomization design, stratification, kit management, and resupply logic; and/or direct integration experience with third-party IRT/RTSM platforms (e.g., Almac, Suvoda, Bracket, Veeva Vault RTSM).
• Familiarity with additional EDC platforms (e.g., Veeva Vault EDC, Oracle Clinical One) is a plus.
• Experience in oncology trials (solid tumors or hematologic malignancies) strongly preferred.
• Exposure to eSource, eConsent, or wearable/device integration.
• SAS, R, or SQL programming experience to support data review activities.
• Mandarin language proficiency (spoken and/or written) is a plus, given collaborative relationships with partners in China.

Compensation and Benefits

The expected base salary range for this position is $100,000 - $150,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills.

While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.