Clinical Data Manager, Oncology
Sunrise Systems Inc
- Marlborough, MA
- 8 days ago
- Remote
- $66.98–$73.68 Per Hour
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Skills
- Acceptance Testingunmatched
- Audit Metricsunmatched
- Best Practicesunmatched
- Biostatisticsunmatched
- Biotech and Pharmaceuticalunmatched
- Case Report Form (CRF)unmatched
- Clinical Dataunmatched
- Clinical Data Managementunmatched
- Clinical Information Systemsunmatched
- Clinical Practices/Protocolsunmatched
- Clinical Trialunmatched
- Clinical Trial Managementunmatched
- Communication Skillsunmatched
- Contract Research Organization (CRO)unmatched
- Corrective Actionunmatched
- Cross-Functionalunmatched
- Data Analysisunmatched
- Data Cleaningunmatched
- Data Managementunmatched
- Data Qualityunmatched
- Database Administrationunmatched
- Detail Orientedunmatched
- Drug Developmentunmatched
- Electronic Data Capture (EDC)unmatched
- GCP (Good Clinical Practices)unmatched
- ICH Regulationsunmatched
- Leadershipunmatched
- Maintain Complianceunmatched
- Medical Writingunmatched
- Metricsunmatched
- Multitaskingunmatched
- Oncologyunmatched
- Organizational Skillsunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Quality Controlunmatched
- Quality Metricsunmatched
- Reconciliationunmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Risk Analysisunmatched
- Safety Systemsunmatched
- Standard Operating Procedures (SOP)unmatched
- State Laws and Regulationsunmatched
- Team Playerunmatched
- Trend Analysisunmatched
- Validation Testingunmatched
- Writing Skillsunmatched
Description
Job Title: Clinical Data Manager, Oncology
Location: Remote
Duration: 6 Months on contract
SCOPE:
Job Overview
This position reports to the Executive Director, Clinical Data Management, Oncology and is part of the Oncology Data Management function, which supports Sumitomo Pharma America's clinical development programs by ensuring high-quality, compliant, and inspection-ready clinical trial data. The role is responsible for the end-to-end execution and oversight of clinical data management activities across assigned oncology studies and works closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external vendors.
KEY RESPONSIBILITIES:
Essential Functions Required for the Job
Location: Remote
Duration: 6 Months on contract
SCOPE:
Job Overview
This position reports to the Executive Director, Clinical Data Management, Oncology and is part of the Oncology Data Management function, which supports Sumitomo Pharma America's clinical development programs by ensuring high-quality, compliant, and inspection-ready clinical trial data. The role is responsible for the end-to-end execution and oversight of clinical data management activities across assigned oncology studies and works closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external vendors.
KEY RESPONSIBILITIES:
Essential Functions Required for the Job
- Execute and manage all in house clinical data management activities for assigned oncology trials in accordance with ICH/GCP, regulatory requirements, and internal SOPs.
- Support and contribute to the oversight of CROs and data management vendors, including review of deliverables, metrics, timelines, and issue escalation.
- Perform and/or oversee database build, edit check specification review, UAT planning and execution, database modifications, and database lock activities.
- Conduct ongoing data review, cleaning, query management, and quality control to ensure data accuracy, consistency, and completeness.
- Develop, review, and maintain Data Management deliverables, including:
- Data Management Plans (DMPs)
- CRF Completion Guidelines
- Data Validation Specifications
- Data Transfer Specifications
- Monitor study status metrics (e.g., enrollment, eCRF completion, query aging) and provide regular data management status updates to study teams and functional leadership.
- Collaborate cross functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety to support data reconciliation, analysis readiness, and submission activities.
- Identify operational risks, trends, and data quality issues using metrics, audits, and study insights, and partner with teams to implement corrective actions.
- Support inspection readiness activities, audits, and regulatory inquiries related to clinical data management.
- Ensure adherence to Data Management standards, processes, and best practices.
- Perform other data management related duties as required to support departmental and organizational objectives.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS:
Knowledge, Skills, and Abilities
- Strong working knowledge of clinical data management processes, clinical trial conduct, and regulatory requirements (ICH, GCP).
- Experience with EDC systems, eCRF design, edit checks, data validation, and database lock processes.
- Understanding of oncology clinical trials, endpoints, and data flow preferred.
- Ability to analyze data trends, metrics, and operational risks to inform decision making.
- Strong organizational skills with the ability to manage multiple priorities in a fast paced environment.
- Effective verbal and written communication skills and ability to collaborate cross functionally.
- High attention to detail, problem solving skills, and sound judgment.
- Ability to work independently while contributing effectively as part of a matrixed team environment
Education & Experience Requirements
- Bachelor's degree in a scientific, health related, or quantitative discipline required.
- Minimum 4 years of relevant clinical data management experience in the pharmaceutical or biotech industry, with at least 2 years in a Clinical Data Manager role.
- Oncology experience preferred.
- Equivalent combination of education and experience may be considered.
Compensation:
The hourly rate for this position is between $66.98 - $73.68 per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits:
Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Contact:
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com
Numbers & Facts
| Location | Marlborough, MA (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $66.98–$73.68 Per Hour |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.