Lead Clinical Database Programmer

🕒 Julho 2

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Perspective Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2023

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

💰 $400.000 Grant em 2024-02

Healthcare • Manufacturing • Biotechnology

A Perspective Therapeutics é uma empresa de biotecnologia que se concentra no desenvolvimento de tratamentos inovadores para o câncer por meio de uma classe única de teranósticos. Suas tecnologias proprietárias permitem o direcionamento específico de tumores para tratamento, minimizando a toxicidade para tecidos saudáveis. Ao utilizar radiação, radiofármacos e tecnologias avançadas de imagem, a empresa busca melhorar a eficácia do tratamento e proporcionar melhores resultados para os pacientes com câncer.

Descrição

• Develop, deploy, and maintain study databases to support clinical trial data collection, review, and analysis • Configure study-specific builds within EDC systems and support integrations with external system (e.g., IRT, Central Labs, imaging, ePRO, eCOA, CTMS, eTMF) • Design and create clinical databases optimized for data validation, review, and downstream analysis • Assist in developing and maintaining clinical programming documentation • Program, test, and validate electronic edit checks, data listings, and reports to ensure data integrity and usability • Utilize programming languages (e.g., C#, SQL, SAS) to develop and test data outputs and reporting tools • Perform and document all the database programming activities across the study lifecycle, including initial database build, mid-study updates, and database closeout • Support post-production changes, enhancements, and issue resolution in a controlled and compliant manner • Contribute to the development of appropriate study timelines for database build, validation, and deployment, ensuring alignment with overall study milestones • Apply and promote CDISC standards (e.g., CDASH, SDTM) in database design and data structure • Develop and maintain programming documentation, including specification, validation documentation, and change records • Support regulatory inspections and internal audits by ensuring complete, accurate, and inspection-ready documentation • Contribute to the development and continuous improvement of SOPs, standards, templates, and best practices for database programming • Support the setup, validation, and maintenance of global libraries and standard templates • Partner with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to translate protocol and study requirements into database specifications • Provide technical expertise on EDC capabilities, system integrations, and database design decisions • Build and maintain strong working relationships with internal teams and external partners supporting clinical trials • Serve as technical lead and subject matter expert for clinical database programming • Provide mentorship, guidance, and support to team members • Drive consistency, efficiency, and continuous improvement across clinical database programming processes and tools

🎯 Requisitos

• Master’s or bachelor’s degree in computer science/information technology or life sciences or related field. • Minimum 5 years of experience in Clinical Database Programming. • Knowledge of all the steps and documentations involved in a clinical database build process. • Expertise in drug development processes (trial start-up/execution) and EDC database development. • Proficiency in C-sharp, SQL, SAS, (Python or Java is a plus). • Experience in reports/dashboard development. • Proficiency in Clinical Data Management Systems (e.g., Medidata RAVE, Oracle/Inform). • 3+ years of experience with Medidata RAVE CDMS is a plus. • Proficiency in clinical database programming software and tools. • Strong understanding of the clinical trial process, regulatory requirements (e.g., ICH-GCP), and good documentation process (GDP). • Familiarity with clinical data standards (CDISC, CDASH) and coding standards (MedDRA / WHODrug). • Experience with clinical technologies and regulatory submissions. • Understanding of medical coding database structures (WHODrug, MedDRA).

🏖️ Benefícios

• Must be willing to travel up to 10% of the time, as measured on a calendar quarter.