Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Regulatory Compliance Case Report Forms Clinical Data Management Clinical Database Development Data Quality Assessment Biostatistics Clinical Data Management Data Security User Acceptance Testing (UAT) Auditing Analytics Medical Devices Vendor Management Clinical Database Development Data Management Clinical Data Management Medical Practice Experience

Other Skills

•
Analytical Skills
•
Leadership
•
Microsoft PowerPoint
•
Time Management
•
Teamwork
•
Critical Thinking
•
Prioritization
•
Verbal Communication Skills
•
Relationship Building
•
Problem Solving

Roles & Responsibilities

Bachelor’s degree in a scientific discipline
Minimum of 5 years medical device clinical study experience
Knowledge of GCP, ICH, GDPR and FDA/EU regulatory environments
Expertise in development, validation, and management of clinical study databases and experience with the software life cycle spanning CRF design to database development, testing, discrepancy management, data quality review, data analysis, and final database archival

Requirements:

Manages and develops Case Report Forms (CRFs) for pre- and post-market clinical studies
Interfaces with database vendors to ensure CRF development aligns with database specifications and supports data quality
Performs User Acceptance Testing (UAT) on new or updated databases and implements standardized UAT processes
Drafts Data Management Plans (DMPs) and Data Review Plans for all pre- and post-market studies

HistoSonics, Inc.

About HistoSonics, Inc.

HistoSonics is a venture-backed medical device start-up company developing a non-invasive sonic beam therapy platform and procedure using the science of histotripsy. Histotripsy utilizes the pressure created by focused sound energy to liquify and destroy targeted tissue, including diseased tissue and tumors, at sub-cellular levels. The company’s new platform delivers personalized, tissue specific treatments with precision and control, and without the undesirable side effects of many of today’s interventional and surgical modalities. HistoSonics is led by a team of experienced domain experts and industry leaders with offices in Ann Arbor, Michigan and Minneapolis, MN.

Founded: 2018

Company size: 51 - 200

Website LinkedIn See all jobs →

Job description

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.

Location: Plymouth, MN (Hybrid)

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 Director of 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.

#LI-Remote

#LI-LH1

Ready to apply?

APPLY

Share ·