Associate Director, Clinical Operations (Study Startup)
New
CanadaFull-TimeDirector
Salary165,000 - 210,000 USD per year
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Job Details
- Experience
- 14+ years
- Required Skills
- LeadershipProcess improvement
Requirements
- Bachelor’s or Master’s degree in life sciences, health sciences, or related field
- 14+ years of clinical research experience, preferably within a CRO environment
- Strong experience in clinical operations leadership, study startup, and operational management
- Proven ability to lead teams and drive performance in a fast-paced clinical research setting
- Deep knowledge of clinical trial startup processes, including feasibility, site selection, regulatory, and contract management
- Strong understanding of ICH-GCP guidelines, regulatory requirements, and clinical quality standards
- Excellent leadership, communication, and stakeholder management skills across internal teams and external sponsors
- Experience in process optimization, operational strategy, and continuous improvement initiatives
- Strong business acumen with the ability to manage client relationships and contribute to commercial growth
- Willingness to travel approximately 20–50% as required
Responsibilities
- Lead and oversee clinical study startup teams to ensure timely, high-quality, and compliant execution of all startup activities
- Drive end-to-end startup operations including feasibility, site identification, site selection, regulatory submissions, contracts, and site activation
- Collaborate with Clinical Operations Leads, Project Managers, sponsors, and cross-functional teams to design and execute effective startup strategies
- Monitor startup timelines, KPIs, and operational metrics while identifying risks and implementing mitigation strategies
- Ensure accuracy and completeness of startup deliverables, including regulatory documentation, essential documents, and study trackers
- Oversee site contract and budget negotiations to ensure timely execution and alignment with study objectives
- Provide leadership, mentorship, and performance management for startup teams, including hiring, training, and career development
- Lead process improvement initiatives, SOP development, and adoption of tools and technologies to enhance operational efficiency
- Participate in sponsor meetings, bid defenses, and governance discussions as a startup subject matter expert
- Support audit readiness and ensure compliance with ICH-GCP, regulatory standards, and internal quality frameworks
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