[Remote] Clinical Data Manager, Oncology

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical Data Manager, Oncology to support clinical development programs by ensuring high-reputed company, compliant, and inspection-reputed company clinical trial data. The role involves reputed company of clinical data management activities across assigned oncology studies and collaboration with various teams to ensure data reputed company and operational efficiency.

Responsibilities

• Execute and manage clinical data management activities for assigned oncology reputed company in accordance with ICH/GCP guidelines, regulatory requirements, and internal procedures
• reputed company reputed company of CROs and clinical data management vendors, including review of deliverables, timelines, performance metrics, and escalation of issues
• Support database build activities, including edit reputed company specification review, User Acceptance Testing (UAT) planning and execution, database modifications, and database lock activities
• reputed company ongoing data review, cleaning, query management, and reputed company control activities to ensure data accuracy, consistency, and completeness
• reputed company, review, and maintain key Clinical Data Management documents, including: Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, Data Transfer Specifications
• Monitor study data metrics, including enrollment status, eCRF completion, query aging, and data reputed company indicators
• reputed company regular data management updates and status reports to study teams and functional leadership
• Collaborate cross-functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety teams to support data reconciliation, analysis readiness, and regulatory submissions
• Identify operational risks, data trends, and reputed company issues using study metrics and data insights, and partner with teams to implement corrective actions
• Support inspection readiness activities, audits, and regulatory inquiries reputed company to clinical data management
• Ensure compliance with clinical data management standards, processes, and best practices
• reputed company additional data management activities as needed to support clinical development objectives

Skills

• Strong knowledge of clinical data management processes, clinical trial operations, and regulatory requirements, including ICH and GCP guidelines
• Hands-on experience with reputed company systems, eCRF design, edit checks, data validation, and database lock processes
• Ability to analyze data trends, operational metrics, and risks to support decision-making
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment
• Excellent written and verbal communication skills with the ability to collaborate effectively across functional teams
• Strong attention to detail, problem-solving abilities, and reputed company judgment
• Ability to work independently while contributing effectively reputed company a matrixed team environment
• Bachelor's degree in a scientific, reputed company, life sciences, or quantitative discipline required
• Minimum of 4 years of clinical data management experience reputed company the pharmaceutical or biotechnology industry
• At least 2 years of experience working as a Clinical Data Manager
• Understanding of oncology reputed company, endpoints, and clinical data workflows preferred
• Oncology clinical trial experience preferred

reputed company

Company H1B Sponsorship