TFS HealthScience
Principal Database Programmer
TFS HealthScience, Durham, North Carolina, United States, 27703
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.
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 Responsibilities 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
Benefits 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.
Location Multiple locations in Europe · Hybrid or Remote
Seniority level Not Applicable
Employment type Full-time
Job function Information Technology
Industries Pharmaceutical Manufacturing
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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.
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 Responsibilities 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
Benefits 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.
Location Multiple locations in Europe · Hybrid or Remote
Seniority level Not Applicable
Employment type Full-time
Job function Information Technology
Industries Pharmaceutical Manufacturing
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