Principal Programmer - Veeva EDC

Job Title : Principal Programmer Veeva EDC Experience : 8 years of relevant experience in Veeva EDC programming and : - Lead the technical design, development, and implementation of Veeva EDC studies, ensuring adherence to study protocols, data standards, and regulatory requirements (e.g., GCP, 21 CFR Part 11). - Develop complex custom functions, derivations, and validations within Veeva EDC using the Veeva Formula Language and potentially Vault Java API. - Design and implement integrations between Veeva EDC and other clinical trial systems, such as CTMS, IRT, safety databases, and external data vendors, utilizing the Veeva Vault API and other integration technologies. - Configure and manage Veeva EDC study builds, including form design, edit checks, workflows, user roles, and permissions. - Develop and maintain technical specifications, design documents, and other relevant documentation for Veeva EDC studies and integrations. - Perform thorough testing and validation of Veeva EDC configurations, custom functions, and integrations to ensure accuracy and reliability. - Troubleshoot and resolve complex technical issues related to Veeva EDC studies and integrations, providing timely and effective solutions. - Optimize the performance of Veeva EDC studies through efficient design and implementation of configurations and custom logic. - Collaborate closely with clinical data managers, study managers, biostatisticians, and other stakeholders to understand their needs and translate them into technical solutions within Veeva EDC. - Provide technical guidance, mentorship, and support to other programmers and team members on Veeva EDC best practices and development techniques. - Participate in the development and maintenance of internal standards, guidelines, and procedures for Veeva EDC programming and configuration. - Stay up-to-date with the latest Veeva Vault platform updates, features, and regulatory guidelines. - Contribute to the evaluation and implementation of new Veeva EDC functionalities and technologies. - Participate in audits and inspections, providing technical expertise as required. Technical Skills : - Veeva Vault EDC : Extensive hands-on experience (8 years) in programming, configuring, and implementing clinical trials using Veeva Vault EDC. - Veeva Formula Language : Expert-level proficiency in writing complex formulas, derivations, and validations using the Veeva Formula Language. - Veeva Vault API (Java SDK) : Strong experience in developing custom functions, integrations, and automation scripts using the Veeva Vault Java SDK (Vault API). - Clinical Data Management : Solid understanding of clinical data management principles, processes, and standards (e.g., CDASH, SDTM). - Database Knowledge : Familiarity with relational databases (Oracle, SQL Server) and the ability to write SQL queries for data extraction and analysis. - Integration Technologies : Experience with various integration technologies and protocols, such as REST APIs, SOAP, and web services. - Programming Languages : Proficiency in at least one programming language such as Java, Python, or JavaScript for developing integrations and custom tools. - Regulatory Compliance : Thorough knowledge of regulatory requirements for electronic records and electronic signatures (e.g., 21 CFR Part 11, GCP). - Testing and Validation : Strong experience in performing thorough testing and validation of EDC configurations and custom code. - Scripting (Beneficial) : Experience with scripting languages for automation tasks is a plus. Functional Skills : - Strong analytical and problem-solving skills with the ability to troubleshoot complex technical issues. - Excellent communication (verbal and written) and interpersonal skills to effectively collaborate with cross-functional teams. - Ability to understand and interpret clinical trial protocols and specifications. - Strong attention to detail and commitment to data quality. - Ability to work independently and manage multiple tasks effectively in a fast-paced environment. - Leadership skills with the ability to provide technical guidance and mentorship. - Understanding of the clinical trial process and drug development : - Bachelors degree in Computer Science, Information Technology or a related field. - Minimum of 8 years of relevant experience in Veeva EDC programming and configuration within the pharmaceutical or biotechnology industry. - Proven track record of successfully leading the technical aspects of complex Veeva EDC studies and integrations. - In-depth understanding of Veeva Vault platform architecture and functionalities. - Strong knowledge of regulatory guidelines related to electronic data capture in clinical trials. - Veeva Vault EDC certification is highly desirable (ref:hirist.tech)

Location: in, IN

Posted Date: 5/10/2025