- Location: MN, United States
- Type: Contract
- Job ID: 10530
- Work Setting: On-Site
- Posted: August 11, 2026
- Closing Date: February 12, 2027
- Tax Status: W2
Associate Clinical Data Manager
6-month Contract – Potential for Extension
Onsite – Maple Grove, MN
Must be able to work on a W2
Requirements
6-month Contract – Potential for Extension
Onsite – Maple Grove, MN
Must be able to work on a W2
Requirements
- Assist in the ongoing evaluation of study risk through in-depth review of protocol and plan documentation, validation of risk-related findings with cross-functional teams, and development of systems and process-based controls to mitigate identified risks.
- Lead cross-functional teams during protocol development to identify and document data critical to the reliability of study results and protection of human subjects.
- Manage the development and revision of critical data management processes, including CRF design, edit checks, data listings, and clinical database setup.
- Identify and evaluate residual risks to critical study data and oversee additional mitigation activities, including focused data cleaning, quality activities, targeted site instruction, and study-specific Central and Site Monitoring plans.
- Lead the Clinical Project Team through Case Report Form development and partner with the Study Database Manager through database development and release, including identifying, programming, and testing edit checks.
- Review and analyze subject data, resolve discrepant or aberrant data through study site queries, and identify systemic or significant data quality issues requiring escalation.
- Manage escalations and drive issues to resolution in partnership with Project Management, Site Management, Clinical Science, Biometrics, Safety, and organizational leaders.
- Manage progress toward data cleaning and data freeze/lock targets for regulatory submissions and other identified business needs.
- Manage study-wide issuance and resolution of discrepancies throughout the study lifecycle with support from the Clinical Data Coordinator.
- Perform root cause analysis of discrepancy trends requiring clinical or complex logical judgment and develop system-level countermeasures and process improvements.
- Contribute to the maintenance of data review standards and best practices, ensuring adherence informed by therapy-specific expertise.
- Partner proactively with field and study team personnel to present findings from central monitoring and data review activities, develop resolution and escalation strategies, and manage data quality and study conduct through key milestones and deliverables.
- 5 years of experience in clinical operations or a healthcare-related field.
- Prior experience in data management, project management, life sciences, and/or a technical field.
- Strong analytical and critical thinking skills with related prior data management experience.
- Strong communication and collaboration skills.
- Ability to confidently lead discussions and manage complex regulated studies.
- Experience effectively influencing team decisions toward desired outcomes.
- Knowledge of Good Clinical Practice (GCP) and global regulations for investigational studies.
- Bachelor’s degree in Biology, Health Sciences, Mathematics, Computer Science, or equivalent.
- Certified Clinical Data Manager (CCDM) desired; no certifications required.