Senior Clinical Data Manager - Oncology Data Lead

Orion Corporation; Cambridge (MA); Hybrid; USD 80,000 - 150,000; Full time

Job summary

Orion Corporation, a leading oncology-focused organization, seeks a Senior Clinical Data Manager to lead data management across Phase I–III oncology trials. The role partners with Clinical Operations, Biostatistics, and external vendors to ensure high-quality data for regulatory submissions and decision-making.

The candidate will design eCRFs, oversee database builds, SDTM mapping, and data validation, while driving data quality initiatives and process improvements in a hybrid Cambridge (MA or

Qualifications

• 5+ years of clinical data management experience in pharma/biotech/CRO
• Lead data manager for Phase I–III oncology studies
• Experience with data standards (CDASH/SDTM) and data review
• Experience managing external vendor data and complex data streams
• Strong analytical, communication, and stakeholder management skills

Responsibilities

• Lead all data management activities for oncology studies from protocol to database lock
• Represent data management on cross-functional study teams
• Design and implement eCRFs, database builds, edit checks, and data validation rules
• Support SDTM mapping and data reconciliation with external data sources
• Ensure regulatory submissions readiness and data quality oversight
• Develop and maintain DTA, data specs, and study documentation
• Identify opportunities to improve data quality and automate processes

Skills

Data management

Clinical trials

Data integration

Regulatory compliance

SDTM mapping

Education

Life Sciences degree

Biostatistics background

Tools

Medidata Rave EDC

Job description

Orion Corporation, a leading oncology-focused organization, seeks a Senior Clinical Data Manager to lead data management across Phase I–III oncology trials. The role partners with Clinical Operations, Biostatistics, and external vendors to ensure high-quality data for regulatory submissions and decision-making.

The candidate will design eCRFs, oversee database builds, SDTM mapping, and data validation, while driving data quality initiatives and process improvements in a hybrid Cambridge (MA or