Associate Director, Regional Clinical Study Management
New
J
JobgetherPharmaceutical, Biotechnology, Oncology
BrazilFull-TimeDirector
Salary not disclosed
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Job Details
- Languages
- Fluent English is required.
- Experience
- 10+ years of experience in clinical research, with at least 5 years of experience in clinical project management and/or clinical monitoring preferred.
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree in a scientific, healthcare, or related discipline (Master’s preferred).
- 10+ years of experience in clinical research.
- 5+ years of experience in clinical project management and/or clinical monitoring.
- Demonstrated knowledge of FDA regulations and ICH/GCP guidelines.
- Experience developing trial plans including site monitoring, risk mitigation, and budgets.
- Experience managing CROs, vendors, and external clinical partners.
- Experience mentoring direct or indirect reports.
- Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and MS Project.
- Fluent English.
- Ability to travel 10–25% of the time.
Responsibilities
- Lead the planning, implementation, and conduct of large, global, and complex oncology clinical trials across Phases I–IV.
- Oversee regional clinical study activities, ensuring operational plans, milestones, timelines, and deliverables are met.
- Support the development of the clinical operations team in Brazil, including hiring, training, and mentoring.
- Manage CROs, vendors, consultants, and investigators, including vendor selection and performance management.
- Ensure clinical trials comply with ICH/GCP requirements, local regulations, and internal SOPs.
- Review clinical documentation including protocols, informed consent, and regulatory updates.
- Maintain oversight of Trial Master File activities and support regulatory submissions and inspections.
- Manage clinical trial and program-level budgets, including site budgets and financial reporting.
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