Lead Clinical Data Manager with oncology experience

Note: No sponsorship for this position at this point.

As a Lead Clinical Data Manager with oncology experience, you play a pivotal role in the management of clinical trial data specific to oncology studies.

Study Design and Planning

• Protocol Review: Collaborate with study teams to review and understand clinical trial protocols, particularly focusing on oncology-related endpoints and data requirements.
• Data Management Plan: Develop and implement a comprehensive data management plan (DMP) that outlines data collection, processing, and validation strategies.

Data Oversight and Management

• Data Collection: Oversee the collection of clinical trial data from various sources, including electronic data capture (EDC) systems, laboratory results, and patient-reported outcomes.
• Database Design: Lead the design and configuration of clinical databases to ensure they meet the specific needs of oncology studies, including complex endpoints and safety assessments.

Quality Assurance and Compliance

• Data Quality Control: Implement quality control measures to ensure data integrity, accuracy, and completeness throughout the study lifecycle.
• Regulatory Compliance: Ensure that all data management practices adhere to regulatory standards (e.g., FDA, EMA) and Good Clinical Practice (Google Cloud Platform) guidelines.

Team Leadership and Collaboration

• Team Management: Lead and mentor a team of data managers and associates, providing guidance on best practices and problem-solving strategies.
• Cross-Functional Collaboration: Work closely with clinical operations, biostatistics, and medical teams to ensure alignment on data requirements and project timelines.

Data Analysis and Reporting

• Interim and Final Data Review: Oversee the preparation and review of interim and final datasets, ensuring timely delivery for statistical analysis and reporting.
• Data Query Management: Manage the generation and resolution of data queries, working closely with clinical sites and monitors to ensure timely corrections.

Oncology-Specific Expertise

• Oncology Endpoints: Utilize knowledge of oncology-specific endpoints, such as tumor response rates, progression-free survival (PFS), and overall survival (OS), to guide data collection and analysis.
• Adverse Event Reporting: Ensure proper documentation and reporting of adverse events, including serious adverse events (SAEs), in accordance with regulatory requirements.

Training and Development

• Training Programs: Develop and implement training programs for new data management staff, focusing on oncology data management best practices and tools.
• Continuous Improvement: Foster a culture of continuous improvement by identifying and implementing process enhancements within the data management function.

Strategic Input

• Project Planning: Contribute to project planning and resource allocation, ensuring that data management activities align with overall study timelines and objectives.
• Stakeholder Communication: Act as a primary point of contact for data-related issues, providing updates to stakeholders on data status and resolving any concerns that may arise.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.