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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.

• Handson 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, crossfunctional environment.

• Demonstrated ability to mentor junior team members and share best practices.

Education and Experience

• Bachelor's degree in life sciences or a related field required.

• Minimum 3 years of clinical data management experience in the pharmaceutical or biotech industry.

• Oncology experience preferred.

• Ability to travel.

The base salary range for this role is

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.