Senior Clinical Trial Manager leading clinical trial delivery for ICON, a global healthcare intelligence and research organization. Overseeing start - up, execution, compliance, risks, budgets, and closeout.
About the role
- Clinical Research Associate monitoring Canadian clinical trials for Parexel, a global clinical research organization. Managing site relationships, compliance, data quality, and study delivery.
Responsibilities
- Conduct qualification visits, site initiation visits, monitoring visits, and termination visits at assigned clinical sites
- Generate visit and contact reports
- Build and maintain site relationships as the primary site contact
- Address and resolve site issues and questions
- Oversee study integrity and site delivery from identification through close-out
- Review trial performance and safeguard human-subject rights and well-being in accordance with the protocol
- Develop patient recruitment strategies with clinical sites to meet enrollment timelines
- Ensure compliance with SOPs, protocols and amendments, GCP, and applicable regulatory requirements
- Evaluate reported-data quality and integrity, site efficacy, and drug accountability
- Monitor completeness and quality of regulatory documentation
- Perform site document verification
Requirements
- 18+ months of direct onsite monitoring experience as a Clinical Research Associate (CRA)
- Bachelor's or equivalent degree in biological science, pharmacy, or another health-related discipline
- Strong interpersonal, written, and verbal communication skills within a matrixed team
- Ability to work independently with a sense of urgency and limited oversight
- Client-focused approach and flexibility regarding assignments and new learning
- Ability to manage multiple tasks, evaluate unpredictable scenarios, achieve project timelines, and apply understanding of study protocols
- Honest and ethical work approach
- Strong computer skills, including Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), Microsoft Excel, and Microsoft Word
- Fluency in written and spoken English and French
Benefits
- Bonus incentive program
- Less travel and a lower protocol load compared to industry peers
- World-class technology
- Training catered to individual experience
- Opportunity to work within multiple therapeutic areas
- Career advancement opportunities
- Career growth support through consistent performance discussions and evaluations
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