Clinical Data Associate

Clinical Data Associate (Contract - 12 Months)

Position Summary

We are seeking a Clinical Data Associate to support clinical study data management activities for a 12-month contract assignment. This role will work closely with Data Management leadership and cross-functional study teams to ensure high-quality clinical data is collected, reviewed, reconciled, and maintained in compliance with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal procedures.

The Clinical Data Associate will support study-level data management activities, including document maintenance, data review, query management, reconciliation activities, database quality control, user acceptance testing (UAT), issue tracking, and trial documentation management.

Key Responsibilities

• Assist with the creation, maintenance, and updating of study-related data management documentation, including Data Management Plans, Data Validation Plans, Data Review Plans, and CRF Completion Guidelines.
• Support user acceptance testing (UAT) activities for clinical databases and external data integrations.
• Verify and review external vendor test data against study specifications and requirements.
• Generate, review, and distribute study data listings, reports, and performance metrics.
• Conduct ongoing data review activities to ensure accuracy, completeness, and consistency of clinical trial data.
• Review and manage data discrepancies within electronic data capture (EDC) systems, facilitating timely resolution with study teams and sites.
• Identify and communicate data trends, issues, and risks to appropriate stakeholders.
• Perform reconciliation activities between external data sources and clinical study databases, including safety-related data reconciliation.
• Execute database quality control checks and ensure data management deliverables meet established quality standards.
• Support the maintenance and filing of essential study documentation within electronic trial master file (eTMF) systems.
• Adhere to established data management processes, SOPs, regulatory requirements, and GCP guidelines.
• Contribute to continuous process improvement initiatives and support operational excellence across clinical studies.

Qualifications

Required

• Associate's degree or higher in a scientific, healthcare, life sciences, or related discipline.
• Minimum of 2 years of clinical data management experience within a biotechnology, pharmaceutical, clinical research, or contract research environment.
• Experience working with Electronic Data Capture (EDC) systems.
• Strong organizational, analytical, and problem-solving skills.
• Excellent verbal and written communication skills.
• Ability to work effectively within cross-functional teams in a fast-paced clinical development environment.

Preferred

• Experience with leading EDC platforms such as Medidata Rave or similar clinical data management systems.
• Knowledge of clinical trial processes, GCP regulations, and industry standards.
• Experience supporting data reconciliation, discrepancy management, and clinical database quality review activities.

Contract Details

• Duration: 12-Month Contract
• Schedule: Full-Time
• Industry: Clinical Research / Life Sciences
• Location: Hybrid or Remote (based on business needs)

This opportunity offers the chance to contribute to innovative clinical research programs while working alongside experienced clinical operations and data management professionals.

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