The Director, LATAMl Clinical Operations will provide strategic leadership of the Clinical Operations function in emerging geographic regions, ensuring the successful execution of clinical trials from initiation to completion. As part of the leadership team, you will collaborate closely with cross-functional departments, including project management, regulatory affairs, clinical operations, and business development, to drive regional growth, deliver on client expectations, and support the development of new business opportunities.
Leadership (40%)
- Provide strategic leadership and oversight of clinical operations across the region.
- Develop and implement region-specific strategies to optimize clinical trial delivery, improve efficiency, and enhance operational performance.
- Lead, mentor, and develop a high-performing regional clinical operations team, including clinical project managers, clinical research associates (CRAs), and other operational staff.
- Collaborate with senior management to set and achieve business objectives and regional growth targets
People Operations (20%)
- Oversee the planning, execution, and completion of clinical trials across the region, ensuring adherence to timelines, budgets, and quality standards.
- Monitor regional study progress and resolve any operational challenges that may arise, such as recruitment issues, site performance, and regulatory delays.
- Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable local and international regulations.
Communications (20%)
- Build and maintain strong relationships with key stakeholders, including clients, investigators, site staff, and regulatory bodies.
- Serve as the primary point of contact for regional clinical operations for clients and partners, ensuring timely and effective communication.
- Represent the organization in client meetings, bid defenses, and project reviews.
Financial & Resource Management (10%)
- Ensure optimal resource allocation and utilization, both internal and external, for clinical trials.
- Track key performance indicators (KPIs) and metrics to assess project performance and implement corrective actions when necessary.
Business Development & Growth (10%)
- Support the business development team in identifying new opportunities and expanding the organization's footprint in the region
- Provide insights into the regional market, including trends, challenges, and regulatory developments, to inform strategic business decisions.
Qualifications
- The successful candidate will have a minimum of a Bachelor's Degree (Health Sciences, Clinical Research preferred) with 10 years of progressive Clinical Research experience.
- Demonstrated experience leading all aspects of phase 1-3 trials in the country or region is required.
- In-depth understanding of LATAM clinical trial regulations, ethics committees, and cultural nuances that impact trial execution
- Proven ability to navigate regulatory environments in countries like Brazil, Mexico, Argentina, and Chile
- Previous leadership experience managing cross-functional teams, budgets, and timelines.
- Proven track record in scaling operations and driving efficiency in clinical processes
Working Conditions
- Occasional travel (LATAM, North America)
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