Job Details

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

Additional Duties (Based on Qualification)

• 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

• Hybrid or Remote

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

Information Technology

Industries

Pharmaceutical Manufacturing