Associate Director, Regional Clinical Study Management

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Regional Clinical Study Management based in Brazil.

This is a senior clinical operations leadership role overseeing complex oncology studies across the region. You will lead the planning, execution, and operational delivery of Phase I–IV clinical trials, working across multiple functions and external partners. The role combines strategic oversight with hands-on project management, quality leadership, and team development. You will coordinate CROs, vendors, investigators, and internal stakeholders to ensure studies remain on track, compliant, and aligned with development objectives. Your expertise will directly contribute to data quality, patient safety, regulatory readiness, and successful clinical development. The position offers an opportunity to shape regional clinical operations while mentoring teams and driving continuous process improvement. It is well suited to an experienced clinical research leader who thrives in complex, collaborative, and highly regulated environments.

Accountabilities:: Lead the planning, implementation, and conduct of large, global, and complex oncology clinical trials across Phases I–IV, or multiple smaller early-phase studies.

Oversee regional clinical study activities with a high degree of autonomy, ensuring operational plans, milestones, timelines, and deliverables are clearly defined and achieved.

Support the development of the clinical operations team in Brazil, including hiring, training, resource allocation, mentoring, and oversight of external FSP resources.

Act as the primary clinical operations point of contact for protocol execution, coordinating study teams and ensuring effective delivery across sites and partners.

Manage CROs, vendors, consultants, investigators, and other external stakeholders, including vendor selection, performance management, issue resolution, and governance.

Establish and monitor study milestones, metrics, timelines, risks, and escalation processes, ensuring management has accurate and timely visibility into study performance.

Ensure clinical trials comply with ICH/GCP requirements, applicable federal and local regulations, internal SOPs, and quality standards.

Review and provide input into clinical documentation, including protocols, informed consent materials, Investigator Brochures, regulatory updates, monitoring reports, and other study-related documents.

Oversee monitoring activities, review clinical monitoring reports, and ensure outstanding findings and follow-up actions are resolved promptly.

Maintain oversight of Trial Master File activities, conducting periodic reviews to ensure completeness, accuracy, and compliance throughout the study lifecycle.

Support regulatory submissions and participate in Quality Assurance and regulatory authority inspections, including preparation and response activities.

Ensure clinical data quality and integrity across assigned studies and participate in relevant governance committees and cross-functional program forums.

Partner with clinical supply teams to ensure accurate forecasting and availability of clinical and non-clinical supplies according to protocol requirements.

Manage clinical trial and program-level budgets, including site budgets, vendor payments, change orders, financial projections, and reporting in collaboration with Finance and Legal teams.

Support CRO bid defenses and vendor selection activities, including scope-of-work development, budget assessment, and performance evaluation.

Provide cross-functional leadership to ensure clinical program timelines and objectives are achieved.

Mentor junior clinical operations professionals and contribute to team development, performance management, training, SOP development, and operational improvement initiatives.

Requirements:

Bachelor’s degree or higher in a scientific, healthcare, or related discipline; a Master’s degree is preferred.

10+ years of experience in clinical research, with at least 5 years of experience in clinical project management and/or clinical monitoring preferred.

Strong experience managing clinical trials, ideally within the pharmaceutical, biotechnology, or oncology sector.

Demonstrated knowledge and practical application of current FDA regulations, ICH/GCP guidelines, and applicable clinical research requirements.

Experience developing trial plans covering areas such as site monitoring, pharmacy and laboratory manuals, risk mitigation, budgets, site selection, and feasibility.

Experience managing CROs, vendors, consultants, and external clinical research partners.

Prior participation in regulatory authority inspections is strongly preferred.

Strong clinical operations, project management, organizational, and leadership capabilities.

Excellent written and verbal communication skills, with the ability to communicate effectively with study teams, investigators, sites, cross-functional stakeholders, and external partners.

Strong negotiation and collaboration skills, with the ability to manage competing priorities and resolve complex operational issues.

Therapeutic or medical knowledge, particularly in oncology, is preferred.

Experience managing and mentoring direct or indirect reports, including performance discussions, development planning, delegation, and constructive feedback.

Strong proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and MS Project.

Fluent English is required.

Ability to travel approximately 10–25% as required by clinical operations and study activities.

Benefits:

Hybrid work model based in São Paulo, Brazil.

Opportunity to lead regional clinical operations for complex oncology studies across Phase I–IV development programs.

Senior-level exposure to global clinical development, regulatory, and cross-functional teams.

Professional growth through leadership responsibilities, mentoring, and operational improvement initiatives.

Opportunity to work with multidisciplinary internal teams, CROs, investigators, vendors, and external clinical partners.

Exposure to high-impact clinical research programs and complex international study environments.

Travel opportunities of approximately 10–25% in support of regional clinical activities.

The original job posting does not specify salary, healthcare coverage, bonus structure, or additional benefits; these details should be confirmed during the hiring process.

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