Clinical Research Project Manager, Sponsor Oversight

The Hospital for Sick Children; Toronto; Hybrid; CAD 70,000 - 100,000; Full time

Job summary

An established industry player in pediatric healthcare seeks a Clinical Research Project Manager to lead the oversight of investigator-initiated clinical trials. This pivotal role involves ensuring compliance with regulatory standards, managing trial start-up activities, and supporting grant applications. Join a dedicated team committed to improving children's health through innovative clinical research. With a focus on equity, diversity, and inclusion, this organization values contributions that make a meaningful impact in the community. Embrace the opportunity to work in a hybrid environment that promotes work-life balance and employee wellness.

Benefits

Health Coverage

Dental Coverage

Employee Wellness Programs

Work-Life Balance Support

Qualifications

• 5+ years of experience in regulated clinical trials management.
• Knowledge of Health Canada, FDA regulations, and ICH GCP.

Responsibilities

• Oversee study start-up activities for investigator-initiated clinical trials.
• Support grant application planning and budgeting during the pre-award phase.
• Act as the primary sponsor contact for projects.

Skills

Clinical Trials Management

Regulatory Compliance

Analytical Skills

Organizational Skills

Communication Skills

Project Management

Data Management

Education

Bachelor's Degree

Master's Degree

Tools

Microsoft Office

Electronic Data Management Systems

Job description

Clinical Research Project Manager, Sponsor Oversight

Join to apply for the Clinical Research Project Manager, Sponsor Oversight role at The Hospital for Sick Children.

SickKids is dedicated exclusively to children and their families, being one of the largest and most respected paediatric healthcare centres worldwide. We lead and collaborate in child health innovation through healthcare, research, and education. Our reputation is built on the skills and experience of our staff, and we are committed to ongoing learning, a supportive work environment, and high standards of practice.

When you join SickKids, you become part of a community committed to our vision of Healthier Children. A Better World. We offer the opportunity to work alongside the best in paediatric healthcare.

The Regulatory and Compliance Office within Clinical Research Operations seeks a highly motivated Clinical Research Project Manager with extensive experience in clinical trials management and sponsor oversight. As part of our efforts supporting Precision Child Health (PCH), we aim to develop a robust regulatory and compliance program to oversee investigator-initiated clinical trials, streamline processes, and standardize SOPs for safe, high-quality trials.

Our team supports study teams across the institution in establishing SickKids-sponsored clinical trials. We are seeking a Clinical Research Project Manager to oversee the setup activities for these trials from a sponsor’s perspective.

Key Responsibilities:

• Work with investigators to oversee study start-up activities for investigator-initiated clinical trials, ensuring compliance with policies and regulations.
• Support grant application planning and budgeting during the pre-award phase.
• Collaborate with investigators to develop study protocols and documents in line with regulatory standards.
• Assist in developing data management, project management, and safety management plans.
• Oversee the development of data management plans, database setup, and UAT documentation.
• Manage Trial Master Files and sponsor study files.
• Coordinate site selection for multi-centre investigator-initiated trials.
• Facilitate meetings with study teams and external parties to clarify sponsor responsibilities.
• Ensure legal agreements and relevant documents are in place before trial activation.
• Act as the primary sponsor contact for projects.
• Provide ongoing support and guidance to participating sites.
• Assist in regulatory inspections and ensure compliance prior to site activation.
• Contribute to policy and SOP development for sponsor oversight activities.
• Escalate issues and opportunities to leadership as needed.
• Represent SickKids on committees and in presentations.
• Perform other duties as assigned by the Sr. Manager.

Essential Qualifications:

• Bachelor's degree required.
• Minimum of 5 years regulated clinical trials management experience.
• Knowledge of Health Canada, FDA regulations, TCPS2, and ICH GCP.
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple activities and demonstrate initiative.
• Proficiency in electronic data management and Microsoft Office.
• Commitment to equity, diversity, and inclusion.

Preferred Qualifications:

• Master's degree.
• Experience with audits or inspections.
• Certifications such as SoCRA or ACRP.

Benefits:

• Competitive employee benefits, including health and dental coverage.
• Focus on employee wellness and work-life balance.

Impact:

• Work in an organization that values equity, diversity, and inclusion.
• Contribute to improving children's health and making a meaningful impact.

Employment Details: Full-time, permanent, hybrid position.

We encourage applicants from diverse backgrounds and provide support during the hiring process. Only shortlisted candidates will be contacted. Employment is contingent upon providing necessary documentation.

How to Apply:

Combine your cover letter and resume into one document (max 20 pages). For technical assistance, email [e-mail]. Note that resumes sent to this email will not be accepted.