Clinical Data Manager

🔥 0 minutes ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $105k - $130k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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HistoSonics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2009

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

HistoSonics, Inc. is a pioneering medical technology company that has developed a non-invasive sonic beam therapy platform using a treatment called histotripsy. This innovative approach harnesses focused ultrasound to mechanically destroy targeted liver tumors at a sub-cellular level. HistoSonics is dedicated to advancing the science of histotripsy, aiming to provide transformative benefits for patients and physicians worldwide, particularly through its ongoing clinical trials and educational programs.

📋 Description

• 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

• 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

• 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

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