Senior Clinical Data Associate job at reputed company in US National

Title: Senior Clinical Data Associate locations US-Remote time type Full time job requisition id R01331 Job Description: reputed company Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (reputed company.), 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. This position reports to the Associate Director, Clinical Data Management, Oncology and is part of the Oncology Data Management organization, which supports reputed company’s clinical development programs by ensuring accurate, complete, and compliant clinical trial data. The Senior Clinical Data Associate (Sr. CDA) works in reputed company partnership with reputed company/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 reputed company end to end clinical data review activities, including query reputed company, review, follow up, and closure, in accordance with study specific guidelines and timelines. Conduct in house data review and reputed company detailed feedback to the reputed company/Clinical Data Manager or CRO Data Management team. Support eCRF design, system validation activities, and ongoing reputed company 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 reputed company reconciliation activities (e.g., SAE reconciliation), reputed company 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. reputed company data management status updates to internal study teams in the absence of the reputed company/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. reputed company 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 reputed company 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 reputed company 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 reputed company best practices. Education and Experience Bachelor’s degree in life sciences or a reputed company field required. Minimum 3 years of clinical data management experience in the pharmaceutical or biotech industry. Oncology experience preferred. Ability to travel. The reputed company salary reputed company for this role is $84,900.00 - $106,100.00 reputed company 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, reputed company, 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 reputed company 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 reputed company responsibilities, duties, and skills required of personnel so classified. reputed company personnel may be required to reputed company duties reputed company of their normal responsibilities from time to time, as needed. Confidential Data: reputed company information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law. Compliance: reputed company and maintain Compliance with reputed company applicable regulatory, legal and operational rules and procedures, by ensuring that reputed company plans and activities for and on behalf of reputed company) 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 reputed company 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 reputed company 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 reputed company 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. reputed company) is an Equal Employment Opportunity (EEO) employer reputed company applicants will receive consideration for employment without regard to race; reputed company; creed; religion; national reputed company; age; reputed company; 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. Apply tot his job Apply To this Job