Associate Clinical Data Manager (CDM)

Maple Grove- Minnesota

Job Summary

We are seeking a detail-oriented and organized Associate Clinical Data Manager (CDM) to support the management of clinical trial data throughout the study lifecycle. The Associate CDM will work closely with Clinical Operations, Biostatistics, Statistical Programming, Medical, and other cross-functional teams to ensure clinical data is accurate, complete, consistent, and available for analysis.

The ideal candidate will have experience with clinical data management processes, EDC systems, data validation, query management, and clinical trial documentation, preferably within a pharmaceutical, biotechnology, or CRO environment.

Key Responsibilities

• Support clinical data management activities from study start-up through database lock.
• Assist with the development, review, and maintenance of Data Management Plans (DMPs) and related study documentation.
• Support the design, development, and testing of Electronic Data Capture (EDC) databases and clinical data collection forms.
• Review clinical data for completeness, accuracy, consistency, and compliance with study requirements.
• Generate, review, and resolve data queries in collaboration with clinical sites and study teams.
• Perform data review and validation activities to identify discrepancies, missing data, and potential data quality issues.
• Assist with the development and execution of data validation checks.
• Support reconciliation of clinical data from external sources such as laboratories, ECG, imaging, ePRO/eCOA, and other vendors.
• Assist with SAE reconciliation and review of safety-related data, as applicable.
• Maintain accurate clinical data management documentation and tracking logs.
• Support database testing, user acceptance testing (UAT), and database release activities.
• Participate in study team meetings and provide updates on data management activities and issues.
• Work closely with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, and other functional teams.
• Assist with database cleaning activities and preparation for database lock/freeze.
• Ensure activities are performed in accordance with applicable SOPs, ICH-Google Cloud Platform, regulatory requirements, and project-specific procedures.
• Identify potential data quality risks and escalate issues to the Clinical Data Manager or study lead.

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Statistics, or a related field.
• 5 years of experience in clinical data management, clinical research, or a related clinical development function.
• Understanding of clinical trial data management processes and terminology.
• Experience with EDC systems and clinical data review.
• Familiarity with data queries, data validation, discrepancy management, and database cleaning.
• Strong attention to detail and analytical/problem-solving skills.
• Good written and verbal communication skills.
• Ability to manage multiple priorities and work effectively in a cross-functional team environment.
• Proficiency with Microsoft Excel and other standard office applications.

Preferred Qualifications

• Experience working in a pharmaceutical, biotechnology, CRO, or clinical research organization.
• Experience with EDC platforms such as Medidata Rave, Oracle Clinical/Clinical One, Veeva EDC, or similar systems.
• Familiarity with CDISC standards, including SDTM and CDASH.
• Knowledge of clinical data reconciliation and external data integration.
• Experience with clinical trial systems such as CTMS, eTMF, and safety databases.
• Familiarity with SQL, SAS, or other data analysis tools is a plus.
• Knowledge of ICH-Google Cloud Platform, FDA, EMA, and applicable clinical research regulations.