Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
Over 7 years of clinical data management experience in biotech or pharmaceutical industries.
Experience with oncology clinical trials data and its specific requirements.
Expert proficiency in Medidata Rave EDC for configuration and programming.
Strong knowledge of clinical research processes and relevant regulatory guidelines (FDA, ICH, GCP, CDISC).
Demonstrated experience with CRO and vendor management.
Excellent project management skills, capable of handling multiple studies at once.
Responsibilities
Lead clinical data management for oncology trials, ensuring timelines, budgets, and quality standards are met.
Provide strategic direction to CRO teams managing clinical data for assigned studies.
Develop and execute data management plans and validation strategies aligned with protocols.
Oversee the design and validation of clinical databases using Medidata Rave EDC.
Review clinical data to identify trends and resolve quality issues that may affect outcomes.
Collaborate with cross-functional teams to align data management with clinical development goals.
Oversee and manage external data management vendors.
Maintain best practices and standard operating procedures for data management processes.
Represent Clinical Data Management in various meetings, offering expert data-related insights.
Stay updated on trends, regulations, and technology in clinical data management, especially in oncology.
Benefits
Opportunities for professional development and advancement within the field.
Access to cutting-edge technology and resources in data management.
Collaborative work environment with interdisciplinary teams.
Involvement in innovative oncology clinical trials.
Flexible work arrangements may be available.
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.
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)
