Lead and manage clinical data management activities for multiple 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.
Lead the selection, oversight, and performance management of external data management vendors.
Develop and 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 8+ years of clinical data management experience in the biotechnology or pharmaceutical industry, with at least 3+ years in a leadership role.
Extensive 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

Bonus
Stock options
Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical data managementdata management planscase report formsedit checksdata validation plansclinical databasesMedidata Rave EDCproject managementanalytical skillsproblem-solving skills

Soft skills

leadershipcommunication skillsinterpersonal skillscollaborationattention to detail