Clinical Data Manager

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Collaborate with data science and clinical operations teams to guarantee the accuracy, reliability, security, and usability of clinical research data.

• Ensure the collection of relevant data to support regulatory submissions, marketing claims, and prospective histotripsy applications.

• Partner with stakeholders to ascertain that the necessary data elements are captured during CRF development.

• Oversee and create CRFs for both pre- and post-market clinical studies.

• Coordinate with database vendors regarding database development and CRF implementation.

• Conduct User Acceptance Testing on new database builds and updates.

• Formulate methods to enhance and standardize UAT testing.

• Manage feedback for database vendors from the company.

• Draft Data Management Plans and Data Review Plans.

• Supervise data collection quality, including pre-specification and identification of data queries during trials.

• Collaborate with the Data Science team during formal statistical analyses to enhance data accuracy processes.

• Develop clinical metrics for both external and internal purposes.

• Ensure and oversee timely data locks for reporting and regulatory submissions.

• Assist with both internal and external audits.

• Report to the Senior Manager, Clinical Data Science.

⛳️ Requirements

• Bachelor’s degree in a scientific discipline.

• At least 5 years of experience in medical device clinical studies.

• Familiarity with and experience in GCP, ICH, GDPR, and FDA/EU regulatory environments.

• Understanding of clinical data management standards for medical devices.

• Proficiency in the development, validation, and management of clinical study databases.

• Experience throughout the clinical database software life cycle, from CRF design to database development and testing, discrepancy management, data quality review, data analysis, and final database archival.

• Experience as a Clinical Research Associate, or in developing, validating, and/or administering clinical systems for data collection or clinical data analysis, is a plus.

• Exceptional written and verbal communication skills.

• Strong analytical, critical thinking, and problem-solving skills, with the ability to interpret and analyze data.

• Proven collaboration and leadership capabilities.

• Ability to cultivate and maintain internal and external relationships.

• Capacity to prioritize multiple tasks and deadlines while demonstrating excellent follow-through.

• Track record of translating strategic plans into operational objectives.

• Ability to manage shifting priorities in a fast-paced environment while maintaining communication with team members and management.

• Proficient in Microsoft Office, Word, and PowerPoint.

• Must be able to lift 20 lbs.

• Capability 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 occasionally drive to local site locations and meetings.

🏝️ Benefits

• 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.