Principal Database Programmer

📋 Description

• Deliver training and mentorship to (Senior) Database Programmers concerning CDMS systems and processes executed by Database Programmers.

• Strategically plan client deliverables and oversee project budgets.

• Serve as the programming lead for a study or program.

• Establish study databases and ePRO/IRT (when applicable) in accordance with provided specifications (e.g., dummy CRF pages, study design specification, URS).

• May create or review the Database Validation Plan.

• Conduct database validation/UAT in conjunction with CDM.

• May assess the Data Validation Plan (DVP) regarding the feasibility of checks in CDMS.

• Program edit checks within CDM systems and/or SAS as per the data validation plan.

• May assist CDM in drafting an edit check test plan.

• May support CDM in the import and export of data processes.

• May aid CDM in the development of data transfer specifications, including coordinating with vendors to facilitate connections between CDMS and other systems.

• May assist CDM in validating Data transfer programming.

• Create and manage user accounts, including access rights (if applicable).

• Provide helpdesk support for users in EDC studies.

• Collaborate with CDM to execute the database lock.

• File and archive essential documents.

• Responsible for escalating any project-related issues or the need for potential SOP deviations.

• Conduct system validation, develop test scripts for system validation, and perform UAT.

• Actively engage in the organization and enhancement of processes to improve operations at TFS (e.g., writing/reviewing SOPs and related documents and conducting training).

• Contribute to proposals involving Data Management and may participate in Bid Defense meetings.

⛳️ Requirements

• Bachelor’s Degree, preferably in life sciences, computer science, or a related field.

• At least 8 years of relevant database programming experience within the pharmaceutical or CRO industry, including 5 years as a Senior Database Programmer.

• Familiarity with various CDMS systems and industry standards pertinent to programming in a GxP environment (e.g., 21 CFR part 11, GAMP).

• Capability to manage multiple tasks to meet deadlines effectively.

• Demonstrated leadership abilities.

• Exceptional verbal and written communication skills.

• Proficient in engaging effectively with sponsors and internal clients.

• Willingness and ability to travel occasionally.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional growth.