Senior Clinical Data Programmer(.Net)

Responsibilities

• Programming (Data Engineering)
• Architect and maintain complex programs, ensuring robust data integrity and accuracy.
• Create advanced programs for generating detailed reports and summaries of clinical trial data.
• Design and implement advanced software to ensure data handling and reporting meet stringent regulatory standards.
• Ensure data quality and integrity through rigorous validation and quality control processes.
• Identify, analyze, and resolve complex database issues to ensure seamless operation and data flow.
• Generate complex reports by finding, selecting, acquiring and ingesting data sources utilizing established tools and methods.
• Develop sophisticated automation tools to streamline repetitive tasks, improving efficiency and reducing errors.
• Performs Code reviewes and introduces best practices
• Support data setup (eCRF) desig if needed
• Seeks specialist security knowledge or advice when required to support own work or work of immediate colleagues.
• Data Quality Assurance
• Maintain the highest standards of data accuracy, integrity, and consistency.
• Performs careful analysis of data to produce clear findings
• Detect and verify basic data issues to ensure accuracy and reliability of data and analysis.
• Evaluate data to confirm it meets the requirements for its intended purpose.
• Analyze and understand the context in which data is utilized to ensure relevance and applicability.
• Ensure programs and data handling procedures comply with stringent regulatory standards
• Exhibit a proactive and analytical mindset by asking relevant questions and thoroughly investigating data-related problems.
• Execute data preparation and cleansing tasks with precision, following established guidelines and best practiceswith guidance.
• Data Management
• Focus on enhancing data accuracy, accessibility, and actionable insights. Implement project-specific strategies to ensure that data is collected, stored, and analyzed efficiently, supporting the overall goals of clinical research.
• Data Operations
• Support business stakeholders in generation of reports to support efficient business process and outlier reviews
• Ability to interpret concepts, ideas and data to outputs that are understood by the business.
• Independently identify gaps/issues/trends through exploratory data analysis
• Use discussions with stakeholders and understanding of existing available data to pull and provide data driven insights to the business from various systems.
• Documentation
• Participate in review of export requirements specification and external, client documentation
• Document evidence of data findings following internal SOPs and best practices
• Create installation qualification documents and other technical specifications that provide instructions for program execution.
• Contribute to creation and maintenance of documentation for all programming activities and processes.
• Other
• Seeks specialist security knowledge or advice when required to support own work or work of immediate colleagues.
• Carries out any other reasonable duties as requested.
• Functional Competencies (Technical knowledge/Skills)
• Knowledge of clinical vocabulary and healthcare data standards.
• Demonstrable understanding of relevant ICH-GCP Guidelines, local regulatory requirements and SOPs and study specific procedure.
• Significant demonstrable knowledge and understanding of clinical trial data systems, regulatory requirements, and industry standards - CDISC (CDASH/SDTM/ADaM) mapping/specs/conversion/domains/dataset desirable.
• Understanding of clinical trial protocols and case report forms.
• Comprehensive knowledge of Good Clinical Practice: In-depth understanding of clinical trial design and

Benefits

Additional Information

We're on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs & trainings As a Senior Clinical Data Programmer, your core responsibility is to understand complex business requirements and identify strategic opportunities to drive efficiency and value through leveraging data. In this role you will leverage advanced programming languages, scripts, and software tools to perform sophisticated data extraction, transformation, and validation, ensuring the highest standards of data integrity and consistency across critical projects.

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