Lead Clinical Data Manager

Katalyst CRO; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking an experienced Clinical Data Manager to lead oncology data management activities, aligning with study protocols, timelines, and regulatory standards. You will oversee data databases, CRFs, and data validation, while guiding cross-functional teams and external vendors.

The role requires advanced CDM experience in biotech/pharma, strong Medidata Rave skills, and CRO oversight capabilities.

Qualifications

• Minimum 7+ years in clinical data management in biotech/pharma.
• Expert-level Medidata Rave EDC experience.
• Strong knowledge of FDA/ICH, GCP, CDISC standards.
• Experience managing oncology trials and CRO/vendor oversight.

Responsibilities

• Lead and manage clinical data management activities for oncology trials, ensuring timelines, budgets, and quality.
• Provide strategic oversight to CRO CDM teams for assigned studies.
• Develop and implement data management plans, CRFs, edit checks, and data validation plans.
• Oversee design, build, and validation of clinical databases using Medidata Rave EDC.
• Review clinical data to identify trends, inconsistencies, and issues impacting data quality.
• Collaborate with Biostatistics, Clinical Ops, Safety, and Regulatory to align data strategies.
• Provide oversight and performance management of external data management vendors.
• Maintain SOPs, guidelines, and best practices for CDM processes.
• Represent CDM in internal/external meetings, offering expert data guidance.
• Stay current with industry trends, regulatory requirements, and tech advances in oncology data management.

Skills

CDM leadership

Oncology data knowledge

Vendor oversight

Project management

Data quality assurance

EDC programming

MS Office

Education

Bachelor's degree in Life Sciences/CS or related

CCDM� (Certified Clinical Data Manager)

Tools

Medidata Rave EDC

SAS

R

MS Office Suite

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).