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Precision for Medicine

Principal Database Programmer

УдалённоPoland только
Опубликовано
Роль
Инженерия данных
Опыт
Принципал
Занятость
Полная занятость
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Коротко по делу

Principal-level clinical database programmer with 8+ years' experience. Must be able to work remotely from Europe (role listed as Remote, Poland). Requires strong experience with Oracle Rave and Veeva, CDMS/EDC development, CDISC (CDASH/SDTM/ADaM) and demonstrated leadership in database programming.

Ключевые навыки

Oracle RaveVeeva

Обязательные навыки

EDCCDMSC#C++VBSMicrosoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook

Обязательные языки

English

Чем предстоит заниматься

  • Maintains responsibility of assigned projects and ensures on-time delivery.
  • Communicates the status of projects to internal teams and study teams.
  • Maintains awareness of key contract elements and scope of work for assigned projects and communicates status updates to the Project team.
  • Performs project forecasting of hours, identification of resource requirements and manages project budgets including identification of out-of-scope work and post production changes.
  • Provides input and guidance to the design of clinical databases to the client and internal teams.
  • Builds and supports clinical databases.
  • Develops, tests, and validates programs and clinical databases to support client-related projects and third-party applications.
  • Provides system administration and advanced technical support services for internally developed applications and clinical databases, client-related projects and third-party applications.
  • Troubleshoots and resolves software and clinical database problems.
  • Develops and maintains study-specific validation documents.
  • Provides support to data management for client-related projects from CRF design to post database close and archival.
  • May design, develop and validate the Company’s internal applications, client-related projects and third-party applications.
  • Participate in software vendor selection.
  • Participate in conducting EDC demonstrations and trainings.
  • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities.
  • Supports onboarding of new hires and provides operational and technical training to end users and junior staff.
  • Provide leadership for cross-functional and organization-wide initiatives, where applicable.
  • Trains and ensures that all data management project team members have been sufficiently trained.
  • Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues.
  • Present software demonstrations/trainings, department/company training sessions, present at project meetings.
  • Performs all duties in accordance with SOPs, government regulations, guidelines and industry standards.
  • May require some travel.
  • Perform other duties as assigned.

Что требуется

  • 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 to include 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: Experience in a clinical, scientific or healthcare discipline and multiple therapeutic area experience
  • Preferred: Experience in utilizing various Database Programming systems
  • Preferred: Ability to work independently, manage time and create plans to achieve project revenue and business goals
  • Preferred: Ability to work effectively with minimal direction; must be self-motivated and self-directed
  • Preferred: Team player willing to collaborate and share knowledge
  • Preferred: Highly organized with effective communication, interpersonal and negotiation skills
  • Preferred: Exceptional customer service orientation and proven track record of successful client relationship management

Clinical Research

HealthcareКрупнаяprecisionformedicine.com/

Что говорят о компании

2.8/ 5

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