Clinical Data Management Associate II

Accountabilities: Clinical Data Management: Support the implementation and execution of clinical data management plans for assigned medical imaging studies, ensuring data collection and management activities meet project requirements. Study Documentation Review: Review study documentation, protocols, and project requirements to assess their impact on data management processes, standards, and deliverables. Data Validation & Quality Control: Define, develop, execute, review, and maintain edit checks to identify inconsistencies, discrepancies, and missing information while ensuring clinical data accuracy and completeness. Clinical Data Review: Analyze clinical and imaging-related datasets to identify data quality issues, trends, inconsistencies, and potential errors requiring investigation. Data Specifications & System Configuration: Develop and maintain study-specific documentation, including data transfer specifications, system configuration specifications, and data validation requirements. Cross-Functional Collaboration: Work closely with project teams and operational stakeholders to support study setup, data collection strategies, and changing project requirements. Issue Management & Resolution: Investigate data discrepancies, coordinate resolution activities, track outstanding issues, and ensure timely follow-up with relevant stakeholders. Reporting & Data Deliverables: Prepare, review, validate, and deliver ad hoc data listings, study reports, and other data-related outputs according to project requirements. Documentation & Compliance: Create and maintain transmittal forms, study documentation, and accurate audit-ready records throughout the clinical study lifecycle. System & Process Improvements: Identify system defects, bugs, and opportunities for enhancements, coordinating with Product Management and relevant technical teams to support improvements. Stakeholder Communication: Provide regular updates on project progress, data quality concerns, potential risks, and outstanding issues to supervisors and project stakeholders. Continuous Improvement: Contribute to departmental improvement initiatives, standard operating procedure (SOP) updates, and quality enhancement activities. Regulatory Compliance: Ensure data management activities follow internal procedures, Good Clinical Practice (GCP), and applicable regulatory and industry requirements. Requirements Bachelor's degree in Computer Science, Life Sciences, Healthcare, Clinical Research, Data Science, or a related discipline, or equivalent professional experience. At least 3 years of experience in Clinical Data Management, clinical research, biotechnology, pharmaceuticals, Contract Research Organizations (CROs), or related healthcare environments. Good understanding of clinical trial processes, clinical data review methodologies, and clinical database management principles. Working knowledge of relational database concepts, data validation techniques, and quality control methodologies. Experience developing or maintaining data specifications, edit checks, data transfer requirements, or clinical study configuration documentation is preferred. Familiarity with clinical research terminology, medical imaging data, and regulated research environments. Proficiency in Microsoft Office applications, particularly Word, Excel, Access, Outlook, and PowerPoint. Strong analytical and problem-solving abilities, with the capacity to investigate discrepancies and resolve complex data quality issues. Exceptional attention to detail and a strong commitment to maintaining data accuracy, consistency, and integrity. Excellent organizational, documentation, and time-management skills, with the ability to manage multiple priorities and deadlines. Strong written and verbal communication skills in English, including the ability to communicate technical and project-related information clearly. Ability to work independently, demonstrate initiative, and collaborate effectively with cross-functional and geographically distributed teams. A proactive, professional, and customer-focused approach, with a strong sense of accountability and commitment to continuous improvement. Ability to adapt to changing project requirements while maintaining high standards of quality and compliance. Benefits Competitive compensation package and performance-related incentives. Provident fund benefits. Medical insurance coverage. Flexible remote working opportunities within India. Access to modern office facilities and collaborative working environments. Employee engagement programs and local team events. Professional development and continuous learning opportunities. Career growth opportunities within an international organization. Exposure to global clinical research projects and medical imaging technologies. Opportunity to contribute to clinical studies supporting the development of life-changing therapies. Collaborative and purpose-driven work environment focused on scientific innovation and improving patient outcomes.