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Precision Medicine Group

Principal Database Programmer

RemoteEU
Published
Role
Data Engineering
Experience
Principal
Employment
Full-time
Salary not disclosed
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Open to Anywhere in EU. Set where you work from to check your eligibility.

No BS summary

Principal-level clinical database programmer with 8+ years' experience. Must have strong Medidata Rave and Veeva experience, CDISC knowledge (CDASH/SDTM/ADaM) and clinical database/CDMS development skills. Role is full-time, permanent and can be covered remotely from European locations (listed as Remote, Slovakia).

Core skills

RaveVeeva

Required skills

C#C++VBSMicrosoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft OutlookCDISC (CDASH, SDTM, ADaM)CDMSEDC

Optional skills

Experience in utilizing various Database Programming systems

Required languages

English Professional

What you'll do

  • Manages all programming aspects of the database (development testing, implementation, maintenance and support of clinical databases and applications) from study start to post database lock for assigned projects.
  • Works closely with other departments and interfaces directly with internal team and external teams (Data Management, Project Management, EDC vendors, clients and third-party vendors) to provide status updates and gather requirements.
  • Leads the operational study team and programming team members on assigned studies and study programs.
  • Provides operational and technical training to end users and junior staff.
  • Provides planning estimates for project scope, schedule/timelines, forecasting, and resource requirements.
  • Maintains responsibility of assigned projects and ensures on-time delivery; communicates project status to internal teams and study teams.
  • Maintains awareness of key elements of the contract and scope of work for assigned project(s) and communicates status updates to the Project team.
  • Performs project forecasting of hours, identifies 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 database 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, 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 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, and 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.

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 adventage
  • 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: 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 a self-motivated and self-directed individual who enjoys a challenging and dynamic work environment
  • Preferred: Team player willing to collaborate and share knowledge
  • Preferred: Highly organized
  • Preferred: Effective communication, interpersonal and negotiation skills
  • Preferred: Excellent organization and prioritization skills
  • Preferred: Exceptional customer service orientation and proven track record of successful client relationship management
HealthcareEnterprise
Salary not disclosed