Clinical Data Manager

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties. We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most. Location: Plymouth, MN (Remote)

Position Summary:

The Clinical Data Manager will integrate with both the data science and clinical operations teams to ensure the accuracy, reliability, security, and usability of clinical data collected during clinical research. This position will play a critical role in ensuring collection of appropriate data to support regulatory submissions, marketing claims, for future applications of histotripsy. The Clinical Data Manager will report to the Senior Manager, Clinical Data Science.

Key Responsibilities:

• Works with key stakeholders to ensure appropriate data elements are captured during CRF development
• Manages and develops Case Report Form (CRF)s for both pre- and post-market clinical studies
• Works as a liaison with database vendor(s) to ensure proper database development and CRF implementation to the database specifications
• Performs User Acceptance Testing (UAT) on all new database builds or updates to existing databases, develops methods to improve and standardize UAT testing, and manages HistoSonics feedback to the database vendor(s)
• Drafts Data Management Plans (DMP’s) and Data Review Plans for all pre- and post-market studies
• Ensure quality management of data collection, including the pre-specification of data queries and identification of new queries during the conduct of the trial
• Interfaces with the Data Science team during formal statistical analyses to improve processes involving data accuracy
• Works with key stakeholders to develop clinical metrics for external and internal purposes
• Ensures and manages timely data locks in preparation for reporting and regulatory submissions
• May assist in internal and external audits

Qualifications and Skills:

• Bachelor’s degree in scientific discipline
• Minimum of 5 years medical device clinical study experience
• Knowledge of, and experience with, GCP, ICH, GDPR and the FDA/EU regulatory environments
• Understanding of CDM standards for medical devices (pre-market experience preferred)
• Expertise in development, validation, and management of clinical study databases and experience with the software life cycle spanning from CRF design to database development and testing, discrepancy management, data quality review, data analysis, and final database archival
• Experience as CRA, 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 the ability to interpret and analyze data
• Demonstrated collaboration and leadership abilities
• Demonstrated ability to develop and maintain relationships, internally and externally.
• Demonstrated ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills.
• Demonstrated record of converting strategic plans to operational objectives
• Demonstrated ability to handle shifting priorities in a fast-paced environment while maintaining communication with team and manager
• Proficient in Microsoft Office, Word, and Power Point

Specifications/Other:

Working Conditions

• Physical abilities – must be able to lift 20lbs
• Mental abilities – ability to view computer screen for 8 hours per day
• Work may be performed on-site in an office environment with exposure to electrical office equipment
• Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 10% of the time and may periodically drive to local site locations/meetings

Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.