Lead Oncology Data Manager - Medidata Rave & DM Strategy

Katalyst CRO; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking an experienced Senior Clinical Data Manager to lead oncology data management and drive study data quality. You will guide CRO teams, develop data management plans, and oversee Medidata Rave databases to ensure regulatory compliance and timely delivery.

You will collaborate with Biostatistics, Clinical Operations, Safety, and Regulatory to align data strategies with development goals. A CCDM certification and oncology focus are highly valued.

Qualifications

• Bachelor's degree in Life Sciences, CS, or related field; advanced degree preferred.
• 7+ years clinical data management experience in biotech or pharma.
• Experience managing oncology trials data and oncology-specific needs.
• Expert-level Medidata Rave EDC proficiency.
• Strong knowledge of FDA/ICH guidelines, GCP, GCDMP, and CDISC standards.
• Demonstrated CRO and vendor oversight experience.
• Excellent project management and multitasking abilities.
• Strong communication and cross-functional collaboration skills.
• Proficiency in MS Office; SAS or R is a plus.
• CCDM certification.
• Experience with risk-based monitoring in oncology studies.
• Knowledge of ePRO, wearables, AI/ML in data collection and mgmt.

Responsibilities

• Lead and manage clinical data management activities for oncology trials.
• Provide strategic direction to CRO data management teams for studies.
• Develop DM plans, CRFs, edit checks, and data validation plans.
• Oversee design, build, and validation of Medidata Rave databases.
• Review clinical data to identify trends and data quality issues.
• Collaborate with Biostatistics, Clinical Ops, Safety and Regulatory.
• Oversight of external data management vendors.
• Maintain SOPs, guidelines, and best practices.
• Represent Data Management in internal/external meetings as data expert.
• Stay current with industry trends, regulatory changes, and tech advances.

Skills

Project management

Analytical thinking

Cross-functional collaboration

Problem-solving

FDA/ICH knowledge

CDISC standards

Oncology data experience

Data review & QA

Education

Bachelor's degree in Life Sciences/CS/related field

Advanced degree preferred

CCDM certification

Tools

Medidata Rave EDC

Job description

Katalyst CRO is seeking an experienced Senior Clinical Data Manager to lead oncology data management and drive study data quality. You will guide CRO teams, develop data management plans, and oversee Medidata Rave databases to ensure regulatory compliance and timely delivery.

You will collaborate with Biostatistics, Clinical Operations, Safety, and Regulatory to align data strategies with development goals. A CCDM certification and oncology focus are highly valued.