Lead Oncology Data Manager | Medidata Rave Pro

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

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.