Associate Clinical Data Manager

Location: Maple Grove, MN 55311 Work Arrangement: 100% Onsite Schedule: Monday–Friday, 8:00 AM–4:00 PM Contract Duration: 6 months, with a strong likelihood of extension Start Date: ASAP, following completion of onboarding

Position Overview

Viltis is seeking an experienced Associate Clinical Data Manager to support clinical study data management activities for a leading life sciences organization in Maple Grove, Minnesota.

This position will play a key role in ensuring the quality, integrity, and regulatory compliance of clinical study data throughout the study lifecycle. The ideal candidate will bring strong clinical data management experience, excellent analytical and critical-thinking skills, and the confidence to lead cross-functional discussions involving complex, regulated clinical studies.

The Associate Clinical Data Manager will collaborate closely with Clinical Operations, Project Management, Clinical Science, Biometrics, Safety, Site Management, and other stakeholders to identify data risks, manage study databases and data-cleaning activities, and drive studies toward critical data freeze and database lock milestones.

Key Responsibilities

Lead cross-functional teams during protocol development to identify and document data critical to the reliability of study results and protection of human subjects.
Assist with the ongoing evaluation of clinical study risks through detailed review of protocols, study plans, and supporting documentation.
Collaborate with cross-functional teams to validate risk findings and develop appropriate process- and system-based controls.
Manage the development and revision of critical clinical data management processes, including:
- Case Report Form (CRF) design
- Edit checks
- Data listings
- Clinical database setup
- Data-cleaning strategies
Identify and evaluate residual risks to critical clinical study data and coordinate additional risk-mitigation strategies.
Develop focused data-cleaning and quality-management activities based on identified study risks.
Support development of targeted site instructions and study-specific central and site monitoring strategies.
Lead the Clinical Project Team through the development and review of Case Report Forms.
Partner with the Study Database Manager throughout database development, validation, and release.
Identify, program, review, and test edit checks used to identify potential clinical data discrepancies.
Conduct ongoing review and analysis of accumulated subject data.
Identify discrepant, incomplete, aberrant, or inconsistent clinical data and issue appropriate queries to study sites.
Identify systemic or significant data-quality issues requiring escalation and drive issues through resolution.
Partner with Project Management, Site Management, Clinical Science, Biometrics, Safety, and organizational leadership to resolve complex data issues.
Manage study progress toward data-cleaning, data-freeze, and database-lock targets for regulatory submissions and other business requirements.
Work closely with Clinical Data Coordinators to manage the issuance and resolution of study-wide data discrepancies throughout the study lifecycle.
Perform root cause analysis of recurring discrepancy trends requiring clinical or complex logical judgment.
Develop system-level corrective measures and contribute to ongoing process improvement.
Contribute to the development and maintenance of clinical data review standards, procedures, and best practices.
Lead proactive communication with field personnel and clinical study teams regarding findings identified through central monitoring and data-review activities.
Develop, document, and manage appropriate resolution and escalation strategies.
Monitor the overall health of clinical study data quality and study conduct throughout key milestones and deliverables.

Required Qualifications

Bachelor’s degree in Biology, Health Sciences, Mathematics, Computer Science, Life Sciences, or a related technical discipline.
Approximately 5+ years of experience in clinical operations, clinical data management, healthcare, or a related field.
Previous hands-on experience with clinical data management activities.
Experience supporting regulated clinical studies.
Working knowledge of Good Clinical Practice (GCP) and applicable global regulations governing investigational clinical studies.
Experience with clinical database development, CRFs, edit checks, data cleaning, discrepancy management, and/or database lock activities.
Strong analytical and critical-thinking skills.
Ability to evaluate complex clinical data issues and identify appropriate solutions.
Excellent written and verbal communication skills.
Strong collaboration skills and experience working across multidisciplinary teams.
Confidence leading meetings and discussions involving complex clinical or regulatory issues.
Demonstrated ability to influence cross-functional team decisions and drive issues toward resolution.
Strong organizational and project-management capabilities with the ability to manage multiple study priorities and deadlines.

Preferred Qualifications

Certified Clinical Data Manager (CCDM) certification.
Experience managing data for medical device, pharmaceutical, biotechnology, or other regulated clinical investigations.
Experience with risk-based data management and/or centralized monitoring methodologies.
Experience supporting clinical studies through data freeze, database lock, and regulatory submission milestones.
Familiarity with electronic data capture (EDC) systems and clinical trial database platforms.

What Makes Someone Successful in This Role

The successful candidate will be comfortable taking ownership of clinical data-management activities while working within a highly collaborative environment. This role requires someone who can analyze complex information, identify potential study risks, communicate findings clearly, and confidently lead cross-functional teams toward appropriate solutions.

Candidates should be comfortable balancing detailed data review with broader study-level responsibilities and working within the quality and documentation requirements of a regulated clinical environment.