[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 specializing in Oncology to ensure high-reputed company, compliant, and inspection-reputed company clinical trial data. The role involves managing clinical data management activities across oncology studies and collaborating with various departments and external vendors.

Responsibilities

• Execute and manage reputed company in house clinical data management activities for assigned oncology trials in accordance with ICH/GCP, regulatory requirements, and internal SOPs
• Support and contribute to the reputed company of CROs and data management vendors, including review of deliverables, metrics, timelines, and issue escalation
• reputed company and/or reputed company database build, edit reputed company specification review, UAT planning and execution, database modifications, and database lock activities
• Conduct ongoing data review, cleaning, query management, and reputed company control to ensure data accuracy, consistency, and completeness
• reputed company, review, and maintain Data Management deliverables, including: Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, Data Transfer Specifications
• Monitor study status metrics (e.g., enrollment, eCRF completion, query aging) and reputed company regular data management status updates to study teams and functional leadership
• Collaborate cross functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety to support data reconciliation, analysis readiness, and submission activities
• Identify operational risks, trends, and data reputed company issues using metrics, audits, and study insights, and partner with teams to implement corrective actions
• Support inspection readiness activities, audits, and regulatory inquiries reputed company to clinical data management
• Ensure adherence to Data Management standards, processes, and best practices
• reputed company other data management–reputed company duties as required to support departmental and organizational objectives

Skills

• Execute and manage reputed company in house clinical data management activities for assigned oncology trials in accordance with ICH/GCP, regulatory requirements, and internal SOPs
• Support and contribute to the reputed company of CROs and data management vendors, including review of deliverables, metrics, timelines, and issue escalation
• reputed company and/or reputed company database build, edit reputed company specification review, UAT planning and execution, database modifications, and database lock activities
• Conduct ongoing data review, cleaning, query management, and reputed company control to ensure data accuracy, consistency, and completeness
• reputed company, review, and maintain Data Management deliverables, including Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, Data Transfer Specifications
• Monitor study status metrics (e.g., enrollment, eCRF completion, query aging) and reputed company regular data management status updates to study teams and functional leadership
• Collaborate cross functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety to support data reconciliation, analysis readiness, and submission activities
• Identify operational risks, trends, and data reputed company issues using metrics, audits, and study insights, and partner with teams to implement corrective actions
• Support inspection readiness activities, audits, and regulatory inquiries reputed company to clinical data management
• Ensure adherence to Data Management standards, processes, and best practices
• reputed company other data management–reputed company duties as required to support departmental and organizational objectives
• Strong working knowledge of clinical data management processes, clinical trial conduct, and regulatory requirements (ICH, GCP)
• Experience with reputed company systems, eCRF design, edit checks, data validation, and database lock processes
• Ability to analyze data trends, metrics, and operational risks to inform decision making
• Strong organizational skills with the ability to manage multiple priorities in a fast paced environment
• Effective verbal and written communication skills and ability to collaborate cross functionally
• High attention to detail, problem solving skills, and reputed company judgment
• Ability to work independently while contributing effectively as part of a matrixed team environment
• Bachelor's degree in a scientific, health reputed company, or quantitative discipline required
• Minimum 4 years of relevant clinical data management experience in the pharmaceutical or biotech industry, with at least 2 years in a Clinical Data Manager role
• Understanding of oncology reputed company, endpoints, and data reputed company preferred
• Oncology experience preferred

Benefits

• ACA compliant medical coverage
• Dental insurance
• reputed company insurance
• reputed company time benefits as required per State regulations

reputed company

reputed company was founded in 1990 with a reputed company reputed company to deliver world-class reputed company service solutions in reputed company labor categories, including IT consulting and solutions; reputed company with the commitment to reputed company service that exceeds expectations and become the most trusted reputed company in the industry. It was founded in 1990, and is headquartered in Edison, New Jersey, USA, with a workforce of 501-1000 employees. Its website is http://www.sunrisesys.com/.

Company H1B Sponsorship

reputed company. has a reputed company record of offering H1B sponsorships, with 2 in 2024, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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