Director, Clinical Research
TORONTO - FULL TIME
Job Description
As a director of clinical research, you will be responsible for managing and 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 managing the monitoring of sites and data to ensure data quality and contributing to data quality management systems. You will also interact closely with regulatory affairs teams and contribute to regulatory filings and strategy. 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.
Responsibility
- Manage clinical site data collection and clinical study partners
- Oversee clinical support teams and outsourced support
- Establish and/or build on data collection protocols which will qualify for IRB approvals, including managing Informed Consent Forms and Site Agreements
- Build on and Manage Clinical Site Training Procedures including hosting live & virtual Training Sessions for data collection and product deployment and developing and continuously improving training materials, including manuals and videos
- Manage data collection + site communications including close monitoring of early data-acquisition and live feedback + further integration with product and R&D teams
- Contribute to Regulatory/ FDA Materials and strategy
Requirements
- Experience in managing clinical studies which resulted in FDA clearances
- 5+ year clinical research experience including management of programs and/or people. CTA, CDM or RAM background.
- 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
- Sonography or radiology experience a plus
Attributes
- 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 get the results and support you need.
