Clinical Trial Manager II – Early Phase

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

📋 Description

• Manage and oversee clinical investigative sites and clinical monitoring deliverables for Early Phase clinical trials.

• Assist the PM, EPTR in supervising clinical monitoring and ensuring timely, high-quality deliverables that comply with monitoring plans, budgets, SOPs, regulations, GCP, and study requirements.

• Identify risks, quality concerns, and trends associated with site performance and clinical monitoring activities.

• Summarize findings and formulate corrective action plans.

• Act as a point of contact for CRAs and Lead CRAs on assigned projects.

• Mentor and supervise CRAs and Lead CRAs.

• Oversee the review of site visit reports and track metrics related to site visit reports.

• Contribute to Clinical Monitoring Plans and provide project-specific CRA and site training.

• Develop annotated site visit reports and monitoring tools.

• Conduct quality control visits and co-monitoring visits alongside CRAs.

• Contribute to the content of CRA meetings and clinical operations project performance indicators.

• Engage in business development activities, including client meetings, proposal defense meetings, RFPs, and RFIs.

• For selected studies, manage trial timelines, budgets, resources, and vendors as the primary Sponsor contact.

• Coordinate tasks and deliverables across various functional departments.

• Manage project budgets, review billed hours, and identify out-of-scope activities for change orders.

• Guarantee that study documents and project deliverables are created on time and meet study requirements.

⛳️ Requirements

• Bachelor’s degree in a field relevant to clinical research, nursing degree, and/or equivalent experience.

• Minimum of 5 years of clinical research experience, including prior monitoring experience.

• At least 2 years of experience in a Lead CRA or Clinical Team Leader role within the biotechnology, pharmaceutical, and/or CRO industry.

• Proficient in English (excellent oral and written communication).

• In-depth knowledge of ICH/GCP standards and relevant regulatory requirements.

• Exceptional proficiency in Microsoft Office suite (Word, Excel, PowerPoint).

• Capability to thrive in a fast-paced, evolving environment while building strong relationships with colleagues, sites, and sponsors.

• Outstanding leadership, organizational, time management, and multitasking abilities.

• Excellent judgment and problem-solving skills.

• Willingness to travel up to 30% of the time.

• Candidates must be legally authorized to work in Canada.

• Experience in a CRO and in dermatology is a plus.

🏝️ Benefits

• Engaging work environment.

• Attractive opportunities for advancement.

• Fair treatment and equal opportunity.

• Accommodations available throughout the recruitment and selection process for applicants with disabilities, upon request.