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\xe2\x80\x99s Personal Information Protection and Electronic Documents Act (PIPEDA) and Ontario\xe2\x80\x99s Personal Health Information and Protection Act (PHIPA) and regulations on Personal Information/Health Information Protection in applicable global markets.
ISO 14155:20120Clinical investigation of medical devices for human subjects \xe2\x80\x94 Good clinical practice
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 with preparation of relevant materials such as research ethics board applications and grant submissions
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? Simply click the apply button with your updated CV and we will reach out soon. 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
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