Bachelor's degree in Life Sciences, Computer Science, or related field; advanced degree preferred.
Minimum of 7+ years of clinical data management experience in biotechnology or pharmaceutical industry.
Experience managing oncology clinical trials data with a deep understanding of oncology-specific requirements.
Expert-level proficiency with Medidata Rave EDC, including configuration and programming.
Strong knowledge of FDA & ICH guidelines, GCP, GCDMP, and CDISC standards.
Demonstrated experience in CRO and vendor oversight.
CCDM® certification is a plus.
Responsibilities
Lead clinical data management for oncology trials, meeting timelines and quality standards.
Provide strategic direction to CRO data management teams for assigned studies.
Develop and implement data management plans and CRFs aligned with protocols.
Oversee clinical database design and validation using Medidata Rave EDC.
Conduct data reviews to identify trends and resolve issues impacting study outcomes.
Collaborate with cross-functional teams to align data management strategies with clinical goals.
Manage performance of external data management vendors.
Benefits
Opportunity to work at the cutting edge of oncology clinical trials.
Engage in strategic oversight, enhancing project management skills.
Exposure to cross-functional collaboration among health sciences professionals.
Professional development support in emerging technologies like AI/ML and ePRO.
Possibility to influence data management processes within the organization.
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).
