Senior Clinical Operations Lead

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee the clinical operations of a project on a specified regional or global scale.

• Ensure project deliverables, Clinical Research Associates (CRAs), and Investigator sites are managed in line with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines, and local regulations.

• Serve as the primary point of contact between the CRAs and the clinical project team.

• Additional tasks include providing project-specific training for CRAs, conducting assessment visits with CRAs, implementing enrollment and recruitment strategies, preparing the monitoring plan and other essential documentation, and overseeing monitoring visit scheduling, site performance metrics, issue escalation, and corrective actions.

• Develop study tools for site and CRA utilization, review visit reports, track protocol deviations, and support various objectives for clinical operations and the clinical project team.

⛳️ Requirements

• A college diploma or degree AND 7-9 years of relevant experience, along with continuous training and skill enhancement.

• OR

• An undergraduate university degree (Bachelor's or Honors Bachelor's) AND 4-6 years of experience, supplemented by significant ongoing job-related training.

• A minimum of 3 years of CRA experience is required, with strong proficiency in EDC systems, MS Office, excellent written and verbal communication skills, and effective interpersonal and organizational capabilities.

• Must exhibit attributes such as proactivity, attention to detail, task orientation, and strong organizational skills.

• A solid understanding of the critical aspects of GCPs and local regulations related to clinical monitoring, IRB/EC, and Investigator responsibilities is essential.

• Proven ability in report writing and a strong capacity to critically analyze clinical research documents.

• Capable of managing multiple tasks to meet deadlines in a fast-paced environment.

🏝️ Benefits

• Preference for candidates with a Health Sciences, Life Sciences, or Nursing specialty, or those with SoCRA and/or ACRP Certification/Designation.