Planet Pharma
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Senior EDC Programmer
The Senior EDC Global Library Programmer serves as a technical subject matter expert responsible for the development, programming, validation, maintenance, and governance of the Medidata Rave Global Library and reusable study build components supporting clinical development programs.
Reporting to the Senior Director, Clinical Data Systems & Ops Ex, this senior individual contributor role partners closely with Clinical Data Management, Statistical Programming, Biostatistics, Clinical Operations, Quality, Regulatory, Information Technology, and external partners to implement approved clinical data standards and optimize study build efficiency. The individual will develop and maintain reusable eCRFs, edit checks, custom functions, study templates, and metadata standards while ensuring compliance with GCP, regulatory requirements, and company procedures.
The successful candidate will provide technical leadership in the application of CDISC standards, support protocol implementations and study amendments, oversee testing and validation activities, and drive continuous improvement initiatives that enhance data quality, consistency, and operational efficiency across the clinical portfolio.
Design, program, maintain, and govern Medidata Rave Global Library components including folders, forms, fields, matrices, data dictionaries, edit checks, derivations, and custom functions.
Develop and maintain reusable study templates, and standardized build components that support consistent implementation of data collection standards across clinical studies.
Implement approved CDASH standards, CDISC controlled terminology, metadata conventions, and naming standards to ensure consistency and traceability from data collection through analysis and submission.
Program, troubleshoot, and maintain Rave edit checks, derivations, and custom functions using C#, ensuring accuracy, performance, scalability, and maintainability.
Support new study builds, protocol amendments, and production changes by evaluating impacts on data collection, edit checks, integrations, reporting, and downstream datasets.
Author and review specifications, technical documentation, validation records, release packages, test scripts, and implementation guidance supporting library and study deployments.
Perform component, integration, regression, and user acceptance testing (UAT), investigate defects, document root causes, implement corrective actions, and maintain complete testing evidence.
Maintain version control, release management, change history, traceability documentation, and implementation records for Global Library components and study-specific configurations.
Partner with Data Management, Statistical Programming, Biostatistics, Clinical Operations, Regulatory Affairs, Quality Assurance, Information Technology, and external vendors to support study delivery and standards implementation.
Support external data integrations and reconciliation activities involving laboratories, imaging vendors, biomarkers, eCOA platforms, randomization systems, and other clinical technology solutions.
Evaluate requests for new standards and study-specific exceptions, assess impacts on existing studies and reusable components, and provide technical recommendations to governance stakeholders.
Serve as a technical advisor for study teams and vendors regarding Rave standards, library components, implementation strategies, troubleshooting, and approved design exceptions.
Assess impacts of Medidata platform upgrades and system changes and support validation activities required to maintain a compliant and inspection-ready environment.
Develop training materials, work instructions, and technical guidance documentation and mentor team members on Rave programming best practices and standards implementation.
Monitor library adoption, release performance, defects, deviations, and operational metrics and drive continuous improvement initiatives across data standards and study build processes.
Manage multiple priorities and deliverables across concurrent studies and standards initiatives while maintaining high quality and adherence to timelines.
Bachelor’s degree in Computer Science, Information Systems, Life Sciences, Statistics, Data Science, or related discipline with 8+ years of relevant experience in biotechnology, pharmaceutical, or CRO environments. Alternatively, a Master’s degree with 6+ years of experience is acceptable.
Minimum of 6 years of hands-on Medidata Rave EDC programming experience, including at least 4 years of study build, configuration, and implementation experience.
Demonstrated experience developing, maintaining, and governing reusable Medidata Rave Global Library components utilized across multiple clinical studies.
Strong expertise in Rave Architect, eCRF design, edit checks, derivations, study configuration, and custom function development utilizing C#.
Practical knowledge of CDASH, SDTM, CDISC controlled terminology, and the relationship between clinical data collection and submission-ready datasets.
Experience authoring specifications, conducting peer reviews, supporting UAT, executing validation activities, and documenting controlled production changes.
Working knowledge of GCP, ICH guidelines, GCDMP principles, 21 CFR Part 11 requirements, computerized systems validation practices, and clinical data integrity expectations.
Experience supporting external data integrations, data exports, reconciliation processes, and cross-functional technical troubleshooting.
Strong analytical, problem-solving, and decision-making skills with the ability to assess study impacts and implement effective technical solutions.
Excellent written and verbal communication skills with demonstrated ability to influence stakeholders and effectively communicate technical concepts across organizational levels.
Ability to work independently, prioritize multiple assignments, and thrive in a fast-paced, innovative clinical development environment.
Medidata Rave Study Builder Certification and advanced training in Rave custom functions, architecture, or Global Library development.
Sponsor-side experience establishing, enhancing, or managing enterprise Rave standards, study build, or governance capabilities.
Oncology clinical trial experience, including exposure to Phase I through Phase III development programs and regulatory submission activities.
Experience supporting complex study designs, adaptive trials, early-phase oncology studies, pediatric studies, or other specialized clinical populations.
Knowledge of CDISC Library APIs, metadata repositories, CDISC ODM, Rave Web Services, or similar metadata management and integration technologies.
Experience with SQL, Python, automation tools, reporting platforms, or metadata quality assessment solutions.
Familiarity with additional EDC platforms and emerging clinical trial technologies.
Strong collaboration, mentoring, and stakeholder management skills with demonstrated success working across global and cross-functional teams.
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