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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing global study start-up processes, ensuring compliance with ICH guidelines and local regulations, while effectively communicating with sponsors and regulatory bodies. Proficient in preparing essential documents and conducting quality checks to facilitate successful submissions.
Highest-signal resume keywords
Study Start-Up ManagementHealth Canada SubmissionsICH Guidelines KnowledgeRegulatory Submissions ExperienceBilingual Proficiency (English and French)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Study Start-Up Lead ExperienceQuality Checks on Submission DocumentsInformed Consent Form PreparationRegulatory ComplianceProactive Problem Solving
Soft Skills
Effective CommunicationPresentation SkillsCollaboration
Industry Keywords
CRO ExperienceEthics SubmissionsGlobal Start-Up ManagementBid Defense PresentationsAudit Participation
About the role
Key responsibilities & impact- Efficiently manage and successfully execute all aspects of global start-up
- Perform quality checks on submission documents and site essential documents
- Prepare and approve informed consent forms
- Serve as a Sponsor point of contact for start-up and regulatory submissions items
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges
- Present during bid defenses, general capabilities meetings, and audits
Requirements
What you’ll need- Bachelor’s degree in a science or health-related field
- At least 5 years of study start-up Lead/Manager experience at a CRO
- Study start-up experience with Health Canada and Ethics submissions
- Knowledge of ICH guidelines and applicable local regulations
- Proficiency in English and French is a plus
Benefits
Comp & perks- Competitive compensation programs that recognize and reward performance
- Comprehensive health, wellness, retirement, and PTO benefits
- Office based culture with occasional WFH that provides flexibility for eligible positions after training
- Company-sponsored social events
- Office based environment with on-site mentors
- Defined career paths with clear advancement opportunities
- Industry renowned onboarding and training programs designed to accelerate professional development
- Ongoing training and continuous learning opportunities throughout your career
- An environment that encourages employees to influence change, contribute ideas, and grow quickly