AD Clinical Operations/Sr. CTM
Associate Director / Senior Clinical Trial Manager - Health Canada (Contract) Location: Remote (Preference for candidates able to be onsite in the Boston office approximately one day per week) Duration: 9-Month Contract Schedule: Full-Time | 40 hours per week About the Opportunity An emerging, science-driven biotechnology organization focused on advancing innovative therapies for movement disorders is seeking an experienced Associate Director / Senior Clinical Trial Manager to provide strategic and operational leadership across clinical programs. This individual will play a key role in driving execution of global clinical studies and ensuring operational excellence across all phases of trial delivery. The ideal candidate combines strong clinical operations leadership with a hands-on approach and thrives in a fast-paced, collaborative environment. Experience managing complex clinical studies in neurology and/or movement disorders is desirable. Required Canadian Clinical Operations Experience Demonstrated experience leading or supporting Canadian clinical site activation activities, including a strong understanding of applicable regulatory requirements, ethics submissions, and provincial/site-specific processes. Qualified candidates should possess:
- Experience navigating Canadian clinical startup requirements and operational workflows
- Working knowledge of Health Canada submissions and country-specific startup considerations
- Experience with Research Ethics Board (REB) submissions and approvals
- Familiarity with provincial and institution-specific activation requirements across Canadian sites
- Proven ability to coordinate startup activities while maintaining study timelines and regulatory compliance
Position Summary The Associate Director / Senior Clinical Trial Manager will be responsible for overseeing the planning, implementation, and execution of clinical trials while partnering closely with cross-functional stakeholders, CROs, vendors, and study teams. This role requires a strategic thinker who can also execute at a detailed operational level to support study success, timelines, quality, and budget objectives.
Key Responsibilities
- Lead day-to-day operational management of assigned clinical studies from study startup through closeout
- Drive clinical trial execution and ensure studies remain on track regarding timelines, quality, budget, and milestones
- Develop and oversee study plans, startup strategies, enrollment projections, risk mitigation plans, and operational deliverables
- Partner closely with Clinical Development, Medical, Regulatory, Data Management, Biostatistics, Clinical Supply, and external vendors
- Manage CRO and vendor relationships, including performance oversight and issue escalation
- Monitor study progress and proactively identify operational risks and implement mitigation strategies
- Oversee clinical trial documentation and ensure inspection readiness and compliance with applicable regulations and SOPs
- Participate in study team meetings and provide operational leadership and strategic recommendations
- Support site selection, startup, enrollment strategies, and study execution activities across domestic and international regions
- Contribute to process improvements and operational best practices across the clinical organization
- Required Qualifications
- Bachelor’s degree in life sciences or related field
- Approximately 8+ years of progressive clinical operations experience within biotech, pharmaceutical, or CRO environments
- Demonstrated success managing complex clinical trials with increasing operational responsibility
- Experience functioning at a Senior Clinical Trial Manager or Associate Director level
- Strong working knowledge of ICH-GCP guidelines and global clinical trial regulations
- Experience managing external vendors and CRO partnerships
- Ability to independently manage multiple priorities in a dynamic environment
- Excellent communication, organizational, and cross-functional leadership skills
This role represents an opportunity to contribute meaningfully to the advancement of therapies addressing significant unmet needs within movement disorders while partnering with a passionate and mission-driven team.