Study Start-Up Project Lead – Canada (Flexible & Equity)

Jobgether; Canada; On-site; CAD 95,000 - 130,000; Full time

Benefits offered by this job

Performance-based bonus opportunities

Sign-on bonus (eligibility)

Equity awards (eligibility)

Comprehensive health and wellness

Job summary

Jobgether is seeking a Study Start-Up Project Manager based in Canada to lead global study start-up activities within a fast-paced clinical research environment. You will oversee regulatory submissions, quality checks, and coordination with sponsors and cross-functional teams to keep timelines on track.

The role requires a Bachelor’s degree in a science-related field and at least 5 years in study start-up within a CRO, with strong knowledge of Health Canada regulations and ICH guidelines.

Qualifications

• Bachelor’s degree in a science, healthcare, life sciences, or another relevant field.
• At least 5 years of study start-up Lead or Manager experience within a CRO.
• Experience managing study start-up activities involving Health Canada and Ethics submissions.
• Strong knowledge of ICH guidelines and applicable Canadian and local regulatory requirements.
• Proven ability to manage multiple priorities, timelines, and stakeholders in a complex clinical research environment.
• Strong organizational, problem-solving, and project management skills with a proactive approach to resolving challenges.
• Excellent written and verbal communication skills with sponsors and cross-functional teams.
• Fluency in English; French is an advantage.

Responsibilities

• Manage and execute global clinical study start-up activities with quality and timelines.
• Quality checks of regulatory submission documents and site documentation.
• Prepare and approve informed consent forms per requirements.
• Act as key contact for sponsors on start-up and regulatory submissions.
• Identify challenges from regulations and develop proactive, compliant solutions.
• Coordinate with stakeholders to progress study activation.
• Support audits, proposals, and strategic study discussions.

Skills

Study Start-up Leadership

Regulatory Submissions

Stakeholder Coordination

Education

Bachelor's degree in science/healthcare/life sciences

Job description

Jobgether is seeking a Study Start-Up Project Manager based in Canada to lead global study start-up activities within a fast-paced clinical research environment. You will oversee regulatory submissions, quality checks, and coordination with sponsors and cross-functional teams to keep timelines on track.

The role requires a Bachelor’s degree in a science-related field and at least 5 years in study start-up within a CRO, with strong knowledge of Health Canada regulations and ICH guidelines.