Job Title: Clinical Data Manager – Oncology
Location: 100% Remote
Pay rate: $72/hr
We are seeking an experienced Clinical Data Manager – Oncology to support oncology clinical development programs by ensuring high-quality, compliant, and inspection-ready clinical trial data. This role will manage end-to-end clinical data management activities and collaborate with Clinical Operations, Biostatistics, Safety, Medical Monitoring, and external vendors.
Key Responsibilities:
- Manage clinical data management activities for assigned oncology trials in compliance with ICH/GCP and regulatory requirements.
- Support CRO and vendor oversight, including deliverable reviews, timelines, metrics, and issue resolution.
- Perform database build activities, edit check reviews, UAT execution, database modifications, and database lock processes.
- Conduct data review, cleaning, query management, and quality checks.
- Develop and maintain Data Management Plans, CRF guidelines, validation specifications, and data transfer specifications.
- Monitor study metrics, identify data quality risks, and support inspection readiness activities.
Required Qualifications:
- Bachelor’s degree in scientific, healthcare, or quantitative discipline.
- 4+ years of clinical data management experience in pharmaceutical or biotech industry.
- Minimum 2 years of experience as a Clinical Data Manager.
- Mandatory: Oncology clinical data management experience.
- Strong experience with EDC systems, eCRF design, edit checks, data validation, and database lock activities.
- Knowledge of ICH/GCP and clinical trial processes.
- Strong communication, organizational, and problem-solving skills.
Note: Oncology Data Management experience is a must.
Company Description
Incorporated in 1991, Real Soft Inc. (RSI) is a US-based global software solutions company, a pioneer in providing professional services and delivering business solutions. Our persistent focus has been on forging strong relationships through service excellence and cost containment for customers.
Address:
125 Village Blvd
Forrestal Village, Suite 200
Princeton, NJ 08540