Accountabilities

Oversee clinical monitoring activities and investigative site performance across assigned clinical trials, ensuring deliverables meet sponsor expectations, study timelines, and quality standards.

Ensure all monitoring activities comply with applicable SOPs, regulatory requirements, Good Clinical Practice (GCP), and study-specific procedures.

Identify quality issues and performance trends through project meetings, site communications, monitoring reports, follow-up letters, quality control visits, and audit findings.

Summarize findings and develop action plans to address issues, implement corrective measures, and improve site and monitoring performance.

Serve as the primary point of contact for CRAs and Lead CRAs on assigned projects, providing guidance, mentorship, and operational oversight.

Review site visit reports and monitor reporting metrics to ensure accuracy, quality, and compliance.

Contribute to the development and refinement of Clinical Monitoring Plans.

Prepare and deliver project-specific training for CRAs to ensure consistent understanding of study requirements and monitoring procedures.

Develop annotated site visit reports and monitoring tools, including source data verification worksheets.

Conduct quality control and co-monitoring visits with CRAs to assess performance and reinforce quality standards.

Coordinate and lead CRA meetings, facilitating communication and alignment across clinical monitoring teams.

Support business development activities when required, including client meetings, proposal presentations, and responses to requests for proposals (RFPs) and requests for information (RFIs).

Requirements

Bachelor's degree in a field relevant to clinical research, a nursing degree, or equivalent professional experience.

At least 8 years of clinical research experience, including previous clinical monitoring experience.

Minimum 2 years of experience in a Lead CRA or Clinical Team Leader role within the biotechnology, pharmaceutical, or contract research organization (CRO) industry.

Strong knowledge of ICH/GCP standards and applicable clinical research regulatory requirements.

Excellent command of Microsoft Office applications, particularly Word, Excel, and PowerPoint.

Proven leadership and mentoring capabilities, with the ability to guide clinical monitoring teams and support CRA development.

Strong organizational, time management, and multitasking skills, with the ability to manage competing priorities in a fast-paced and evolving environment.

Excellent judgment, analytical thinking, and problem-solving skills, particularly when identifying and resolving clinical trial operational and quality issues.

Strong interpersonal and communication skills, with the ability to establish effective working relationships with colleagues, investigative sites, and sponsors.

Fluency in written and spoken English; French language skills are considered an asset.

Previous experience in a CRO environment and/or dermatology clinical research is an advantage.

Ability and willingness to travel occasionally, up to 10% of working time, including international travel when possible.

Must be legally authorized to work in Canada.

Benefits

Permanent, full-time employment.

Remote or hybrid work arrangements, with flexibility to work from home or from the office.

Flexible working schedule.

Comprehensive benefits package, including:

Retirement savings plan (RRSP).

Medical, dental, and vision insurance.

Vacation and personal days.

Virtual medical clinic access.

Public transportation discounts.

Social and team activities.

Ongoing learning, training, and professional development opportunities.

Career advancement opportunities within a collaborative and growing organization.

How Jobgether works

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

#LI-CL1