Lead Clinical Data Manager

Katalyst CRO; United States; On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced leader to head clinical data management for oncology trials. You will guide CRO teams, develop data management plans, and ensure data quality and regulatory compliance across studies.

The role requires expert Medidata Rave EDC skills, strong project management, and collaboration with Biostatistics, Safety, and Regulatory groups. Prior CRO experience and CCDM certification are highly valued.

Qualifications

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• 7+ years of clinical data management in biotechnology/pharma.
• Experience with oncology trials and oncology data requirements.
• Expert-level Medidata Rave EDC proficiency with design and edits.
• Strong knowledge of FDA/ICH, GCP, GCDMP, CDISC standards.
• CRO and vendor oversight experience.
• Excellent project management and communication skills.
• CCDM certification and familiarity with risk-based monitoring is a plus.
• Experience with ePRO, wearables, and AI/ML in data management.

Responsibilities

• Lead and manage clinical data management activities for oncology trials.
• Provide strategic oversight to CRO data management teams.
• Develop data management plans, CRFs, edit checks, and validation plans.
• Oversee design and validation of databases using Medidata Rave EDC.
• Review data for trends and issues affecting quality and outcomes.
• Collaborate with Biostatistics, Clinical Operations, Safety and Regulatory.
• Oversee external data management vendors and performance.
• Maintain SOPs and best practices for data management processes.
• Represent the Data Management function in meetings and provide guidance.
• Stay current with industry trends, regulations, and tech in oncology data management.

Skills

Data management leadership

Oncology trials experience

Vendor oversight

Project management

Regulatory knowledge

Communication skills

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

CCDM (Certified Clinical Data Manager)

Tools

Medidata Rave EDC

SAS

R

MS Office

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.

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).