Sumitomo Pharma Co. , Ltd.
pharmaceutical
SeniorClinicalDataAssociate
“Senior Clinical Data Associate at Sumitomo Pharma Co. , Ltd.. Skills: clinical data review, query management, EDC systems, data cleaning, reconciliation. 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.”
What You'll Achieve.
contributes directly to data quality, timeline adherence, and inspection readiness
Industry & Context.
exercise appropriate judgment as necessary
Ability to travel, Ability to travel domestically and internationally as needed, Requires ability to use a personal computer for extended periods of time
What They're Looking For.
Must Have
Bachelor's degree in life sciences or a related field, Minimum 3 years of clinical data management experience in the pharmaceutical or biotech industry, 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
Nice to Have
Oncology experience preferred
What You'll Do.
Perform end to end clinical data review activities
including query generation
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.
system validation activities
and ongoing EDC updates in collaboration with external vendors.
Assist in the development
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.
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
and applicable regulatory requirements.
Perform other assigned duties in support of departmental objectives.
How You'll Work.
Team & Collaboration
works in close partnership with Lead/Clinical Data Managers (LDM/CDM); collaborating closely with Clinical Operations, Safety, Biostatistics, and external vendors; collaboration skills in a matrixed, cross‑functional environment; Provide data management status updates to internal study teams in the absence of the Lead/Clinical Data Manager.
Communication Scope
Effective written and verbal communication skills; Excellent written and oral communication skills
Process & Methodology
ability to manage competing priorities across multiple studies, Take ownership of defined data management tasks or act as the primary Data Management contact for selected projects or study components.
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