Clinical Data Management Associate Specialist

Job Description

Under the direction of senior staff, the Associate Specialist, Clinical Data Management executes core data management activities for assigned trials in accordance with protocols, SOPs, and regulatory requirements. The role supports data entry, validation, reconciliation, query management, and documentation to ensure data quality and audit readiness, contributing to end-to-end study delivery. 

• →Execute clinical data management activities for assigned studies in accordance with defined processes, timelines, quality targets, Standard Operating Procedures (SOPs), International Council for Harmonization – Good Clinical Practice (ICH-GCP), and protocol-specific requirements, working under routine supervision from assigned leadership. 

• →Support clinical data review—defined as reconciliation, logical consistency review, and remediation of study data from multiple sources and data types. Support query management to clinical sites and service providers through resolution in collaboration and alignment with Site Monitoring and Medical Monitoring. 

• →Review, validate, and reconcile data within and across clinical trial data sources and environments, which may include (but not limited to) digital health technologies (DHT), electronic clinical outcome assessments (eCOA), electronic external data (e.g., central laboratories, imaging, biomarkers), vendor/service provider portals, and the clinical database including  site entered or transferred data (e.g., EDC [Electronic Data Capture] or DDC [Direct Data Capture]), ensuring data completeness, consistency, and integrity. 

• →Identify and raise potential data quality issues and risks (e.g., recurring queries, inconsistent data, missing data, late vendor transfers), escalating to assigned leadership with supporting context. 

• →Support specimen and specialty data workflows (as applicable), including tracking and reconciliation for samples, images, and other patient specimens from acquisition through results availability, ensuring appropriate documentation, follow-through, and traceability. 

• →Support verification of protocol-aligned laboratory data setup, including confirmation that laboratories apply protocol-appropriate normal ranges; ensure documentation is filed within the study record. 

• →Contribute to study-level documentation under direction of assigned leadership, including (but not limited to) the Data Management Plan (DMP), Data Validation Plan (DVP), edit check specifications, and electronic case report form (eCRF) completion guidelines/annotations (or equivalent specifications for other modalities), maintaining complete and traceable records to support audit and inspection readiness. 

• →Assist with User Acceptance Testing (UAT) execution and documentation and support change control activities across the study lifecycle. 

• →Collaborate and communicate effectively with the clinical data management team and assigned stakeholders to align priorities, resolve issues within agreed timelines, and close feedback loops to support coordinated, high-quality delivery. 

• →Support additional projects and continuous improvement initiatives as assigned. 

• Basic knowledge of data collection, analysis, trending and summarization in a research or medical setting.  

• Basic understanding of relational database concepts (e.g., tables, keys, data types)  

• Preferred: Experience in data management, medical research, and/or database design or development. 

• Prioritize assigned tasks, meet deadlines, and maintain accurate documentation. 

• Strong attention to detail; follow procedures and data privacy/compliance requirements. 

• Provide clear, timely updates; ask clarifying questions; document concise notes and status. 

• Use basic structured thinking to address issues; escalate appropriately. 

• Build positive, professional, inclusive working relationships with peers, leadership, cross-functional partners, and service providers. 

• Demonstrate reliability and openness to guidance; incorporate feedback quickly. 

• Networking & Partnerships | Develop effective working relationships across teams to support collaboration, coordinate activities, and achieve shared goals. 

• Execution Excellence | Take timely action to accomplish work goals in line with compliance standards, while demonstrating initiative and a proactive approach to achieving results. 

• Ownership & Accountability | Take ownership of assignments, maintain high standards for quality and performance, and accountable for completing work effectively and reliably. 

• Non-Degree with minimum 2 years of experience in data management, clinical trial operations, or a related field 

• [Minimum preferred] Associate’s Degree (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology) with minimum 1 year of experience working in data management or clinical trial operations or related field.  

• Bachelor's Degree (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology, or equivalent education experience) with prior experience working in data management or clinical trial operations or related field preferred.  

• Advanced Degree (Masters or Doctorate) (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology)  

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