Clinical Data Manager

HistoSonics, Inc.

. Integrate with data science and clinical operations teams to ensure accuracy, reliability, security, and usability of clinical research data .

Posted 11/5/2026full-timeRemote • Minnesota • United StatesMid-LevelSenior💰 $105,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical data management, including the development and validation of clinical study databases, regulatory compliance, and data quality assurance. Strong analytical and communication skills are essential for collaborating with cross-functional teams and managing clinical research data effectively.

Highest-signal resume keywords

Clinical Study Database DevelopmentGCP, ICH, GDPR, FDA/EU Regulatory KnowledgeUser Acceptance Testing (UAT)Data Management Plans and Data Review PlansMedical Device Clinical Study Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research Form (CRF) DevelopmentData Quality ReviewStatistical AnalysisData AnalysisDatabase DevelopmentDiscrepancy ManagementClinical Metrics DevelopmentData Collection Quality ManagementDatabase Software Life CycleClinical Data Analysis

Soft Skills

Excellent Written and Verbal CommunicationAnalytical and Critical ThinkingProblem-SolvingCollaboration and LeadershipPrioritization and Follow-Through

Tools & Technologies

Microsoft OfficeMicrosoft WordMicrosoft PowerPoint

Industry Keywords

Clinical Data Management (CDM) StandardsMedical Device RegulationsRegulatory SubmissionsClinical TrialsData Science Integration

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Integrate with data science and clinical operations teams to ensure accuracy, reliability, security, and usability of clinical research data
Ensure collection of appropriate data to support regulatory submissions, marketing claims, and future histotripsy applications
Work with stakeholders to ensure appropriate data elements are captured during CRF development
Manage and develop CRFs for pre- and post-market clinical studies
Liaise with database vendors on database development and CRF implementation
Perform User Acceptance Testing on new database builds and updates
Develop methods to improve and standardize UAT testing
Manage company feedback to database vendors
Draft Data Management Plans and Data Review Plans
Manage data collection quality, including pre-specification and identification of data queries during trials
Interface with the Data Science team during formal statistical analyses to improve data accuracy processes
Develop clinical metrics for external and internal purposes
Ensure and manage timely data locks for reporting and regulatory submissions
Assist with internal and external audits
Report to the Senior Manager, Clinical Data Science

Requirements

What you’ll need

Bachelor’s degree in scientific discipline
Minimum of 5 years medical device clinical study experience
Knowledge of and experience with GCP, ICH, GDPR, and FDA/EU regulatory environments
Understanding of CDM standards for medical devices
Expertise in development, validation, and management of clinical study databases
Experience across the clinical database software life cycle, from CRF design through database development and testing, discrepancy management, data quality review, data analysis, and final database archival
Experience as CRA, or in developing, validating, and/or administering clinical systems for data collection or clinical data analysis, a plus
Excellent written and verbal communication skills
Strong analytical, critical thinking, and problem-solving skills, with ability to interpret and analyze data
Demonstrated collaboration and leadership abilities
Ability to develop and maintain internal and external relationships
Ability to prioritize multiple tasks and deadlines and demonstrate excellent follow-through
Record of converting strategic plans to operational objectives
Ability to handle shifting priorities in a fast-paced environment while maintaining communication with team and manager
Proficient in Microsoft Office, Word, and PowerPoint
Must be able to lift 20 lbs
Ability to view a computer screen for 8 hours per day
Must be willing and able to travel by automobile or air, including day trips and overnight stays, up to 10% of the time
Must be willing and able to periodically drive to local site locations and meetings

Benefits

Comp & perks

Health, dental, and vision insurance
Life insurance
Short-term and long-term disability insurance
401(k)
Paid time off
Comprehensive benefits package for full-time employees