Clinical Trials Manager

Knowledge of FDA regulations and ICH guidelines is required

5+ years of experience in the Clinical Research field

Experience with medical devices is an asset

Advance knowledge of the Canadian regulations and Good Clinical Practices (GCP)

Due to business growth, we are looking for a highly motivated and highly skilled Clinical Research Trials Manager to lead our Clinical Operations. As an integral member of Clinical Operations team, you as the Clinical Research Trials Manager oversees various stages of clinical/research studies.

**Essential Duties and Responsibilities**:

- Monitors and ensures clinical and operational performance standards are maintained at the assigned sites
- Supports the generation, ethics approval, conduct, and analysis of various data collection tools for research trials
- Supports in the conduct of research study visits, as appropriate
- Monitors the progress of research activities; develops and maintains records of research activities
- Responsible for oversight of all project research databases and records
- Plans and coordinates the personnel of research studies including the recruitment and administration of research support staff
- Manages team research coordinators, research assistants, and research students/trainees
- Implementation of clinical research projects in accordance with standard clinical practice and corporate policies and procedures
- Ensure adherence to the protocol providing for accurate data collection, documenting accountability and compliance with federal regulations
- Provide support to field staff, including PIs and study staff
- Provide technical support to clinical sites
- Recruitment of participants for clinical/research studies
- Medical writing according to GCP, ICH guidelines
- Responsible for communicating with different Regulatory Boards and REB submission

**Compliance Responsibilities**:
You as the Clinical Research Trials Manager should ensure compliance with relevant laws and regulations within areas of responsibility including:

- ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.
- Canada Medical Device Regulations
- SOR/98-282 (MDR).
- Food and Drug Administration (FDA), Quality System Regulation (QSR) 21 CFR 820.
- Personal Protection Canada’s Personal Information Protection and Electronic Documents Act (PIPEDA) and Ontario’s Personal Health Information and Protection Act (PHIPA) and regulations on Personal Information/Health Information Protection in applicable global markets.
- Other applicable international regulatory regulations.

**Education**:

- Holds a Graduate degree in health sciences or related field.

**Experience**:

- Knowledge of FDA regulations and ICH guidelines is required
- At least 5 years of experience in the clinical research field
- Experience with medical devices is an asset
- Advance knowledge of the Canadian regulations and Good Clinical Practices (GCP)
- Experience prioritizing and working in a dynamic environment with strong management skills
- Experience working independently with a high degree of initiative, discretion and tact
- Experience working effectively with a wide variety of people at different levels including physicians, industry sponsors and hospital departments
- Experience simplifying complex processes into step-by-step instructions an asset
- Excellent time management, organizational skills and attentional to detail required
- Outstanding written and verbal communication skill
- Ability to travel up to 50% of the time to remote sites in Canada and the US

**Interested?**

**Job Types**: Full-time, Permanent

**Salary**: Up to $120,000.00 per month

**Benefits**:

- Casual dress
- Dental care
- Extended health care
- Paid time off
- Stock options
- Vision care

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Supplemental pay types:

- Bonus pay

Ability to commute/relocate:

- Toronto, ON: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- medical writing: 1 year (preferred)

Work Location: In person