Bachelor's in Life Sciences, Computer Science, or related field; advanced degree preferred.
7+ years of clinical data management experience in biotech or pharmaceutical industry.
Experience managing oncology clinical trials with understanding of oncology-specific data requirements.
Expertise in Medidata Rave EDC, including configuration and programming.
Knowledge of FDA & ICH guidelines, GCP, GCDMP, and CDISC standards.
Experience in CRO and vendor oversight.
Project management skills with ability to manage multiple studies.
Strong analytical, problem-solving skills with attention to detail.
Excellent communication and interpersonal skills.
Familiarity with statistical software (e.g., SAS, R) is a plus.
CCDM® certification and risk-based monitoring experience in oncology studies.
Knowledge of emerging technologies in clinical data management.
Responsibilities
Lead clinical data management for oncology trials, ensuring project timelines and quality standards are met.
Provide strategic direction to CRO data management teams for studies.
Develop data management plans, CRFs, and validation processes aligned with regulatory requirements.
Oversee clinical database design and validation using Medidata Rave EDC.
Review clinical data for trends, inconsistencies, and quality issues.
Collaborate with cross-functional teams on data management strategies.
Manage and oversee external data management vendors.
Maintain SOPs and best practices for data management processes.
Represent Clinical Data Management in meetings with expert guidance on data issues.
Stay informed on regulatory standards and technology advancements in oncology data management.
Benefits
Flexible working arrangements including remote work options.
Opportunities for professional development and continuous learning.
Comprehensive health and wellness programs.
Collaborative work environment with cross-functional teams.
Access to the latest technology and tools in clinical data management.
Full Job Description
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 7+ 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.
CCDM® (Certified Clinical Data Manager) certification.
Experience with risk-based monitoring in oncology studies.
Knowledge of emerging technologies in clinical data collection and management (e.g., ePRO, wearables, AI/ML applications).
