Local Study Associate Director- FSP

About This Opportunity

Our talent team is representing a confidential life sciences organization seeking a Local Study Associate Director to join their FSP division in Canada. This is a fully remote opportunity requiring oncology experience, with cell therapy background strongly preferred.

In this role, you will lead local study teams at the country level, overseeing clinical trial execution from site selection through closeout while ensuring compliance with ICH-GCP and Canadian regulations. You may also perform site monitoring to support flexible capacity needs.

Responsibilities

• Lead Local Study Teams including CRAs and CSAs for assigned clinical studies, ensuring timely delivery of quality data within budget and timeline commitments
• Coordinate site selection, qualification, activation, monitoring, and closure activities across Canadian sites
• Oversee monitoring activities from site activation through study closure, reviewing visit reports and providing proactive guidance to monitors
• Perform co-monitoring and accompanied site visits with study CRAs as needed
• Develop and maintain risk management plans at country level, proactively identifying and mitigating risks
• Ensure timely preparation of country-level consent forms, study agreements, and regulatory submissions to Ethics Committees and Health Canada
• Maintain eTMF in inspection-ready status with complete, timely document uploads
• Manage country financial agreements and budgets, ensuring accurate payments per local regulations
• Plan and lead National Investigator meetings and contribute to patient recruitment strategies
• Coordinate activities for audits and regulatory inspections in collaboration with Quality Assurance
• Train and coach new team members on ICH-GCP compliance and procedural requirements
• Report study progress to global study teams and communicate regularly with site investigators

What We're Looking For

Essential requirements:

• Minimum 3 years in Development Operations (CRA, Senior CRA) or related fields including Medical Affairs-led or Academic-led studies
• Oncology clinical trial experience required
• Cell therapy experience strongly preferred
• Bachelor's degree in life science or related discipline
• Strong knowledge of ICH-GCP and Canadian clinical trial regulations
• Proven ability to lead cross-functional teams and deliver trials on time, within budget, and to quality standards
• Excellent project management, organizational, and communication skills
• Fluency in English required; French language skills beneficial
• Strong negotiation skills and ability to handle multiple priorities with attention to detail
• Ability to travel nationally and internationally as required

Preferred qualifications:

• Strong understanding of drug development processes and clinical study workflows including monitoring
• Medical knowledge and therapeutic area expertise
• Resource management, financial management, and analytical skills
• Coaching and change management capabilities

How We Work with You

Candidates apply directly through Get A Job.ai. Our recruiting team will review your profile and conduct an initial screening. If there's a strong match, we will submit your candidacy to our client for consideration. Please do not attempt to contact the employer directly—all communication flows through Get A Job.ai to ensure a professional, coordinated process.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices. We consider all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.