Clinical Trials Manager
1 day ago
**Overview of the Role**
Parexel is a global biopharmaceutical services company that helps clients get life-changing therapies to patients faster. We are currently seeking a highly skilled and experienced Clinical Trials Manager to join our team in Canada.
**Job Description**
Key Responsibilities:- Lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget, and with required quality.
- Ensure timely preparation of country-level Master Informed Consent Forms (MICFs) and subsequent site-level Informed Consent Forms (ICFs), as required, including any relevant translations.
- Coordinate site selection processes by identifying potential sites/investigators, performing initial Site Quality Risk Assessments, and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Oversee, manage, and coordinate monitoring activities from site activation through to study closure at country and site levels in accordance with Monitoring Plans.
- Review monitoring visit reports (as required and following Client SOPs) and proactively advise monitors on study-related matters.
- Proactively identify risks and facilitate resolution of complex study problems and issues.
- Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations.
- Excellent project management skills.
- Excellent team building and interpersonal skills.
- Excellent organizational skills.
- Excellent verbal and written communication skills.
- Excellent ability to prioritize and handle multiple tasks.
- Excellent attention to detail.
- Proficient in written and spoken English language required.
- Fluency in local language(s) required.
- A competitive salary of $85,000 - $110,000 per year, depending on experience.
- A comprehensive benefits package, including medical, dental, and vision insurance.
- A generous retirement savings plan.
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.
The estimated salary range for this role is based on industry standards and may vary depending on location and experience. The actual salary will be determined during the hiring process.
**Language:** English
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