
1001 - 5000 employees
🏥 Healthcare
💼 Consulting
📦 Logistics
💰 $75M Private Equity Round on 2015-12
Healthcare • Consulting • Logistics
Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.
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1001 - 5000 employees
🏥 Healthcare
💼 Consulting
📦 Logistics
💰 $75M Private Equity Round on 2015-12
Healthcare • Consulting • Logistics
Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.
• Manage all programming aspects of clinical databases and applications from study start to post database lock • Lead development testing, implementation, maintenance and support of clinical databases and applications • Maintain responsibility for assigned projects and ensure on-time delivery • Communicate project status, contract scope and work updates to internal teams and study teams • Forecast project hours, identify resource requirements and manage project budgets, including out-of-scope work and post-production changes • Provide input and guidance on clinical database design to clients and internal teams • Build and support clinical databases • Develop, test and validate programs and clinical databases for client projects and third-party applications • Provide system administration and advanced technical support • Troubleshoot and resolve software and clinical database problems • Develop and maintain study-specific validation documents • Support data management from CRF design through database close and archival • Design, develop and validate internal, client-related and third-party applications as needed • Participate in software vendor selection, EDC demonstrations and trainings • Contribute to SOP and process documentation development and maintenance • Support onboarding of new hires • Lead cross-functional and organization-wide initiatives where applicable • Train data management project team members and end users/junior staff • Communicate with sponsors, vendors and project teams regarding data and database issues • Present software demonstrations, trainings and project meetings • Perform duties in accordance with SOPs, government regulations, guidelines and industry standards • Perform other duties as assigned
• Minimum 8 years’ experience • Bachelors and/or a combination of related experience • Strong experience in Oncology; experience with Autoimmune diseases would be a strong advantage • Strong experience with Rave and Veeva • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • Experience in Object Oriented Programming (C#, C++, VBS, etc.) • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) • Proficiency in more than one CDMS system, including building forms, edit checks and complex rule development • Awareness of CRF standards and input to maintenance of standards library • Ability to troubleshoot and support peers with technical issues and build solutions • Broad knowledge of drug, device and/or biologic development and effective data management practices • Able to handle a variety of clinical research tasks • Excellent organizational and communication skills • Professional use of the English language, both written and oral • Experience in clinical database management system development • Experience in a clinical, scientific or healthcare discipline • Strong leadership and interpersonal skills • Preferred/optional: experience in multiple therapeutic areas; various Database Programming systems; ability to work independently and manage time; ability to work effectively with minimal direction; collaboration and knowledge sharing; organization, prioritization, customer service orientation, client relationship management, negotiation skills
• Full-time, permanent position • Fully remote work from European locations • May require some travel
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Principal Database Programmer managing clinical trial databases and applications for Precision for Medicine. Leading programming, validation, technical support and study teams across European remote projects.