Lead Clinical Database Programmer

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Perspective Therapeutics

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2023

🏥 Gesundheitswesen

🏭 Fertigung

🧬 Biotechnologie

💰 €400.000 Grant im 2024-02

Healthcare • Manufacturing • Biotechnology

Perspective Therapeutics ist ein Biotechnologieunternehmen, das sich auf die Entwicklung innovativer Krebsbehandlungen durch eine einzigartige Klasse von Theranostika spezialisiert hat. Ihre proprietären Technologien ermöglichen die gezielte Behandlung von spezifischen Tumoren, während die Toxizität für gesundes Gewebe minimiert wird. Durch den Einsatz von Strahlung, Radiopharmazeutika und fortschrittlichen Bildgebungstechnologien zielen sie darauf ab, die Behandlungseffizienz zu verbessern und bessere Ergebnisse für Krebspatienten zu erzielen.

Beschreibung

• 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

🎯 Anforderungen

• 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).

🏖️ Vorteile

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