Clinical Data Collection Manager

TORONTO: RESEARCH AND DEVELOPMENT - FULL TIME

Job Description

As a manager of clinical data collections, you will be responsible for establishing data collection protocols with expert KOLs and others, establishing and building relationships with clinical sites and partners, and training and performing data collections on site as needed and warranted. Other duties include monitoring the sites and data to ensure data quality and contributing to data quality management systems.

In this role, your responsibility will grow as we expand our company and our clinical study footprint and this position will expand with and for the right candidate.

• Perform data-collection at and with specified clinics (as needed)
• Initialize clinical site data collection and clinical trial partners
  • Establish and/or build on data collection protocols which will qualify for IRB approvals
  • Manage Informed Consent Forms
  • Manage Site Agreements
• Build on and manage Clinical Site Training Procedures
  • Host live & virtual Training Sessions for data collection and product deployment
  • Develop and continuously improve training materials, including manuals and videos
• Manage data collection + site communications
  • Close monitoring of early data-acquisition and live feedback + further training if needed
  • Point-of-contact for any hardware/ software related concerns & live resolution/ trouble shooting
  • Create regular reports for data collections sites, detailing data quality and necessary changes
  • Monitor site activity and engagement; ensure quarterly targets are met
  • Work closely with App-developers for continuous improvement in data collection flow
  • Remotely implement software updates + communicate and train on any new features
  • Keep track of all deployed hardware and software
  • Monitor and document ultrasound image quality for all incoming data
  • Identify and communicate quality features that can be automated for product design
  • Notify finance team of necessary payments & track costs for all data collection
  • Track patient data volumes and patient data distributions
  • Clean & organize all patient data
  • Carry out data science/statistical analysis of our large data libraries
  • Separate data into sub-sets (train, test etc.) for R&D team
  • Influence feature engineering and signal processing, and coordinate for optimal mining of data
  • Assist in data processing and filtering pipeline
• Contribute to Regulatory/ FDA Materials
  • Own/Contribute to the writing of regulatory submissions
  • Gather and consolidate information from R&D and software development teams
  • Work with consultants and apply changes

• Bachelor’s degree, preferably in clinical studies, Master’s Degree preferred with biostats or related education
• Demonstrated ability to interact effectively and appropriately with high-level professionals, clinicians, and executive staff
• Experience in biostats, data science and/or data quality management
• Medical device experience and SaMD experience a plus
• Database and ML experience a plus
• Sonography or radiology experience a plus

• Great communicator. You have excellent oral and written communication. You effectively communicate and coordinate effectively at every level.
• Exceptional project manager. You are exceptionally skilled at juggling multiple tasks, allocating and optimizing resources, and managing timelines. You manage a task from start to finish, and keep everyone appropriately informed.
• Problem solver. You like to solve a variety of problems – no task is too big or too small. You think ahead, consider all the variables, and anticipate challenges.
• Detail oriented. You are meticulously attentive to details, get it right the first time, and accurately keep track of all the moving parts.
• Autonomous. Although we stay in close communication with each other, we don’t micromanage. We trust you to do your job well without much supervision, but to know when to seek guidance from senior staff. You are comfortable taking initiative.
• Service-driven. You are self-confident and assertive, approachable, and responsive. You understand the mission, needs, and direction of the organization.
• Organizational agility. You have a collaborative work style and are able work across departments to…