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Precision for Medicine

Principal Database Programmer

RemoteRomania only
Published
Role
Data Engineering
Experience
Principal
Employment
Full-time
Salary not disclosed
Check eligibility

Open to RO only. Set where you work from to check your eligibility.

No BS summary

Principal-level clinical database programmer with strong experience in Rave and Veeva. Must have senior experience in clinical database development and CDISC standards; minimum 8+ years. Role is remote for Romania and may be covered remotely from European locations.

Core skills

RaveVeeva

Required skills

C#C++VBScriptCDISCCDASHSDTMADaMCDMSEDCMicrosoft WordMicrosoft ExcelPowerPointOutlook

Optional skills

Experience with Autoimmune diseasesExperience utilizing various Database Programming systemsmultiple therapeutic area experience

Required languages

English Professional

What you'll do

  • Maintains responsibility of assigned projects and ensures on-time delivery
  • Communicates project status to internal teams and study teams
  • Maintains awareness of contract key elements and scope of work for assigned projects
  • Performs project forecasting of hours and identification of resource requirements
  • 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
  • Troubleshoots and resolves software and clinical database problems
  • Develops and maintains study-specific validation documents
  • Provides support to data management 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, EDC demonstrations and trainings
  • Participate in development and maintenance of SOPs and related process documentation
  • 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
  • Trains and ensures project team members have been sufficiently trained
  • Communicate with study sponsors, vendors and project teams regarding data or database issues
  • Present software demonstrations/trainings and department/company training sessions
  • Performs all duties in accordance with SOPs, government regulations, guidelines and industry standards
  • May require some travel
  • Perform other duties as assigned

What they require

  • 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: 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; 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

HealthcareEnterpriseprecisionformedicine.com/
Salary not disclosed