Lead Clinical Data Manager

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

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)