Clinical Research Manager
4 days ago
We are seeking a highly skilled Clinical Research Associate to join our team in the Ontario and Quebec area of Canada.
The ideal candidate will have strong clinical research experience, particularly in cell therapy trials.
Main Responsibilities:
- Manage study sites, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
- Conduct site initiation, monitoring, and closure visits, as well as remote data checks and source data verification.
- Collaborate with local study teams, investigators, and other stakeholders to ensure smooth study execution.
- Develop and implement risk-based quality management strategies to identify and mitigate potential issues.
- Prepare and submit reports, including monitoring visit reports and site quality assessments.
Requirements:
- Bachelor's degree in life sciences or a related field.
- Strong knowledge of GCP, ICH-GCP, and relevant local regulations.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficient in English language; fluency in local language(s) is required.
Desirable Skills:
- Experience with risk-based monitoring approaches, including remote monitoring.
- Familiarity with electronic data capture systems and clinical trial management software.
- Cultural awareness and ability to adapt to diverse environments.
Estimated Salary: $80,000 - $110,000 per year, depending on experience and qualifications. We offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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