Siro Clinpharm
3 weeks ago
Job Description
- We are seeking a highly skilled Veeva CDB Listing Programmer to join our dynamic team.
- The ideal candidate will have extensive experience in programming within the Veeva Clinical DataBase (CDB) environment, with a deep understanding of clinical data management and listing generation.
- This role involves developing, maintaining, and validating clinical data listings to support the clinical trial processes and regulatory submissions.
- Design, develop, and maintain clinical data listings in Veeva CDB.
- This includes creating detailed and accurate reports that reflect clinical trial data as
- Utilize Veeva CDB's programming language and tools to automate listing generation processes, ensuring efficient and error-free output.
- Collaborate with Data Management and Clinical Operations teams to integrate and validate clinical data from various sources into the Veeva CDB system.
- Perform rigorous validation and quality checks on generated listings to ensure compliance with regulatory standards and internal guidelines.
- Create and maintain comprehensive documentation for all programming tasks, including detailed specifications, validation reports, and standard operating procedures (SOPs).
- Work closely with statisticians, clinical data managers, and other stakeholders to understand data requirements and ensure that listings meet study specifications.
- Troubleshoot and resolve issues related to data listings, including identifying and addressing discrepancies and errors in the data.
- Ensure all listings and data handling practices comply with applicable regulatory requirements, including FDA, EMEA, and ICH guidelines.
- Proactively identify areas for process improvement and implement best practices to enhance the efficiency and quality of clinical data listings.
- Bachelor's degree in Computer Science, Data Science, or a related field.
- Experience in clinical data management and programming within the Veeva CDB environment.
- Proven track record of developing and managing complex clinical data listings and reports.
- Proficiency in Veeva CDB programming and configuration.
- Strong knowledge of clinical trial processes and regulatory requirements.
- Experience with statistical programming languages (e.g, SAS, R) is a plus.
- Familiarity with other clinical data management systems and tools is advantageous.
- Excellent problem-solving skills and attention to detail.
- Strong analytical and organizational skills.
- Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
- Ability to manage multiple projects and deadlines efficiently
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