Principal Database Programmer

7 dni temu

Warszawa, Mazovia, Polska TFS HealthScience Pełny etat 80 000 zł - 120 000 zł rocznie

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.

We are currently looking for a Principal Database Programmer. This is a key role responsible for leading and executing database programming activities to support clinical studies, ensuring quality, compliance, and operational excellence.

About the role

As a Principal Database Programmer, you will work operationally on preparing, conducting, and completing clinical data management tasks on assigned study teams in accordance with company policies, SOPs, and regulatory requirements. You will provide technical leadership, mentor junior programmers, and contribute to the development of processes and standards that enhance data management at TFS.

Key Responsibilities
  • Provide training and mentoring to (Senior) Database Programmers on CDMS systems and processes
  • Plan client deliverables and manage project budgets
  • Act as programming lead for assigned studies or programs
  • Set up study databases and ePRO/IRT (if applicable) based on provided specifications
  • Write or review the Database Validation Plan and perform database validation/UAT in collaboration with CDM
  • Review Data Validation Plans for feasibility and program edit checks in CDM systems and/or SAS
  • Support CDM with data import/export and creation of data transfer specifications, liaising with vendors as needed
  • Validate data transfer programming and manage user access rights
  • Provide user support for EDC studies and execute database locks with CDM
  • Escalate project issues or SOP deviations as required
  • Contribute to system validation, including test script creation and UAT execution
  • Participate in process development, SOP writing/review, and related training
  • Provide input to proposals that include data management components and attend bid defense meetings as needed

Depending on your level of qualification, you may also:

  • Perform SAS programming related to data management outputs (e.g. data listings, SAE reconciliation, ad-hoc reports)
  • Develop and validate global SAS macros for data management processes
  • Program/validate SDTM datasets, including define.XML and SDTM reviewer's guides
  • Provide training and mentoring related to SAS programming
Qualifications
  • Bachelor's degree, preferably in Life Science, Computer Science, or a related field
  • Minimum of 8 years of relevant database programming experience in the pharmaceutical or CRO industry, including at least 5 years at a senior level
  • Familiarity with CDMS systems and industry standards applicable for programming in a GxP environment (e.g. 21 CFR Part 11, GAMP)
  • Proven leadership skills and the ability to handle multiple tasks and meet deadlines
  • Excellent verbal and written communication skills
  • Strong ability to work effectively with sponsors and internal teams
What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in patients' lives.

Locations

Multiple locations in Europe · Hybrid or Remote

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