Senior Clinical Data Associate

Job Listing ID:

4490581

Job Title:

Senior Clinical Data Associate Application Deadline:

Open Until Filled

Job Location:

Salem

Date Posted:

05/12/2026

Hours Worked Per Week:

Not Provided Shift:

Not Provided Duration of Job:

Either Full or Part Time, more than 6 months You may contact this employer directly. (Obtain the contact information to print or add to your jobs.)

Job Summary:

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. This position reports to the Associate Director, Clinical Data Management, Oncology and is part of the Oncology Data Management organization, which supports Sumitomo Pharma America's clinical development programs by ensuring accurate, complete, and compliant clinical trial data. The Senior Clinical Data Associate (Sr. CDA) works in close partnership with Lead/Clinical Data Managers (LDM/CDM) and supports multiple oncology studies with increased independence and accountability. The role contributes directly to data quality, timeline adherence, and inspection readiness while collaborating closely with Clinical Operations, Safety, Biostatistics, and external vendors. Job Duties and Responsibilities Perform end to end clinical data review activities, including query generation, review, follow up, and closure, in accordance with study specific guidelines and timelines. Conduct in house data review and provide detailed feedback to the Lead/Clinical Data Manager or CRO Data Management team. Support eCRF design, system validation activities, and ongoing EDC updates in collaboration with external vendors. Assist in the development, review, and maintenance of Data Management documentation, including: Data Management Plans (DMPs) CRF Completion Guidelines Data Validation Specifications / edit checks Data Cleaning and Reconciliation Plans Perform reconciliation activities (e.g., SAE reconciliation), raise and track associated queries, and escalate potential issues to Safety and Data Management leadership. Support interim analysis and database lock activities, including focused data cleaning and reconciliation deliverables. Support management of Lab Normal Ranges for studies with Local Labs. Provide data management status updates to internal study teams in the absence of the Lead/Clinical Data Manager. Take ownership of defined data management tasks or act as the primary Data Management contact for selected projects or study components. Train and mentor junior Clinical Data Associates on assigned tasks and Data Management procedures. Ensure strict adherence to Data Management standards, SOPs, and applicable regulatory requirements. Perform other assigned duties in support of departmental objectives. Key Core Competencies Solid understanding of clinical data management processes and clinical trial conduct under ICH/GCP. Hands-on experience with EDC systems, query management, data cleaning, and reconciliation workflows. Strong attention to detail and ability to manage competing priorities across multiple studies. Ability to work independently with minimal supervision while knowing when to escalate issues. Effective written and verbal communication skills. Strong collaboration skills in a matrixed, cross-functional environment. Demonstrated ability to mentor junior team members and share best practices. Education and Experience Bachelor's degree in life sciences or a related f...

Job Classification:

Data Scientists Access our statewide or regional occupation report for more information about wages, employment outlooks, skills, training programs, related occupations, and more. Compensation

Salary:

Not Provided Job Requirements

Experience Required:

 See Job Summary

Education Required:

None

Minimum Age:

N/A Gender:

N/A