Hybrid Manager, Clinical Data Management

at Summit Therapeutics, Inc.

• Job title: Manager, Clinical Data Management
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $134,500 - $158,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Miami, United States

About the role

• Manager of Clinical Data Management overseeing oncology clinical trials, ensuring data integrity and collaboration with cross-functional teams. Requires strong oncology background and leadership skills.

Responsibilities

• Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards.
• Provide strategic oversight and direction to CRO clinical data management teams for assigned studies.
• Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements.
• Oversee the design, build, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality.
• Conduct thorough reviews of clinical data, identifying trends, inconsistencies, and potential issues that may impact data quality or study outcomes.
• Collaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals.
• Provide oversight, and performance management of external data management vendors.
• Maintain SOPs, guidelines, and best practices for clinical data management processes.
• Represent the Clinical Data Management function in internal and external meetings, providing expert guidance on data-related matters.
• Stay current with industry trends, regulatory requirements, and technological advancements in clinical data management, particularly in the oncology field.

Requirements

• Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
• A minimum of 5+ years of clinical data management experience in the biotechnology or pharmaceutical industry.
• Experience managing oncology clinical trials data, including a deep understanding of oncology-specific data requirements and challenges.
• Expert-level proficiency with Medidata Rave EDC, including system configuration, form design, and edit check programming.
• Strong knowledge of clinical research processes, FDA & ICH guidelines, GCP, GCDMP, and CDISC standards.
• Demonstrated experience in CRO and vendor oversight.
• Excellent project management skills with the ability to manage multiple studies simultaneously.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Outstanding communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders.
• Proficiency in Microsoft Office Suite and familiarity with statistical software (e.g., SAS, R) is a plus.

Benefits

• Bonuses
• Stock options
• Benefits
• Professional development opportunities
• 401(k) matching