Clinical Core Lab and Data Quality Manager

ABOUT 4C MEDICAL TECHNOLOGIES:

We are a small but mighty, well-financed team dedicated to proving the effectiveness of our innovative, life enhancing, life saving therapy. 4C Medical Technologies, Inc., located in Maple Grove, MN, is developing the first Mitral Regurgitation therapy to expand the treatable patient population and streamline the procedure. Our Alta Valve is currently in the clinical trial phase of FDA approval.

JOB SUMMARY:

The Clinical Core Lab and Data Quality Manager is responsible for the management of all Core Lab data, activities and compliance for both early feasibility study and IDE clinical trial. The Clinical Core Lab and Data Quality Manager serves as the primary point of contact for 4C Medical members and Core Lab personnel to provide study support and oversight of Core lab vendors and data from study start up through closure. This role is responsible for the quality, accuracy and timeliness of Core lab data in accordance with study agreements and protocols. Additionally, this role is also responsible for Core Lab image processing through-out the life cycle of both early feasibility study and IDE clinical trial.

JOB RESPONSIBILITIES:

• Conduct ongoing review of Core Lab data to ensure overall quality via proactive and scientifically sound data management.
• Prepare quality Core Lab data & metrics for audits in collaboration with the Clinical Project and the Clinical Data Manager as well as for submissions to regulatory authorities, and publications.
• Organizing, compiling and filing documents relevant to Core Lab activities, including Core Lab and site correspondence.
• Assist in development of Core Lab case report forms (CRFs), investigator guidelines, worksheets and study tools based on clinical protocol.
• Work with EDC vendor and the Clinical Data Manager for Core Lab relevant functional dashboards and metrics.
• Perform Core Lab vendor management activities (e.g., establish and manage relationships, ensure compliance with turn-around-time, data completeness, invoice reconciliation, etc.).
• Assist with site training related to Core Lab study requirements.
• Establish, track, and report on appropriate performance metrics to track trial execution quality and completeness relevant to Core Lab data.
• Develop, maintain and track detailed project timelines specific to Core Lab data and develop contingency plans.
• Support for monitoring, Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) activities relevant to Core Lab data.
• Collaborate with cross-functional team members to develop, validate, and implement internal processes and internal tools to maximize efficiencies.
• Provide input and assist with the development of materials for varied training sessions (e.g., for clinical sites, for internal Clinical Field Specialists, etc.); assist site training and in services as needed.

EDUCATION:

• Bachelor's degree in biology, chemistry, or other related health sciences field.
• 5 to 10 years of investigational clinical trial execution experience.
• Experience and proven leadership and oversight of clinical trial vendors including Core laboratories and data compliance is preferred.

KNOWLEDGE, ABILITIES, SKILLS:

• Deep knowledge of structural heart (or cardiovascular) space is preferred.
• Working knowledge of FDA and ICH/GCP regulations and guidelines.
• Current knowledge of medical evidence with respect to clinical Core Lab data points and best practices across industry.
• Excellent interpersonal communication and project coordination skills.
• Demonstrated ability to collaborate with internal clinical team and external clinical study personnel.
• Demonstrated strong analytical skills.
• Able to independently assess and solve a wide range of complex problems.
• Uses sound judgment for process development and decision making.
• Excellent organizational skills and attention to detail.
• Strong verbal, presentation, written and communication skills.
• Ability to coordinate multiple tasks and re-prioritize promptly as needed to meet business priorities in a fast-paced environment.
• Demonstrated ability to influence direction and decision making.
• Proven ability to work effectively with minimal management direction or supervision.
• Proficient in Microsoft Office Suite.