Senior Clinical Trial Manager managing global Phase 3 clinical trials for oncology at Verastem Oncology. Overseeing vendor management, budget adherence, and regulatory compliance throughout the project lifecycle.
About the role
- Analyst managing documentation for clinical studies at Artha. Engaging with regulatory compliance and supporting research documentation processes.
Responsibilities
- Prepare, review, and standardize clinical research technical documents (protocols, reports, regulatory materials), in Portuguese and English
- Support the structuring and maintenance of regulatory documentation for clinical studies, ensuring traceability, consistency, and compliance
- Prepare dossiers and conduct submissions to the Research Ethics Committee (CEP)
- Update and manage the Document Matrix for studies, ensuring organization, version control, and document governance
- Collaborate with Operational, Quality, and Statistical teams to ensure clarity, applicability, and integrity of documents
- Perform technical and linguistic review of scientific documents
- Support the analysis of scientific literature and the identification of methodologies applicable to studies
- Contribute to continuous improvement of documentation processes and internal standardization
Requirements
- Bachelor’s degree in Biomedicine, Pharmacy, Biology, Nursing, or other Health-related fields
- Intermediate to advanced English (technical reading and writing)
- Strong scientific writing skills and document organization
- Attention to detail and rigor in execution
- Previous experience with undergraduate research, academic research, or technical documentation is desirable
- Knowledge of clinical research, GCP, or regulatory processes is a plus
Benefits
- Health insurance
- Dental insurance
- Flexible working hours
- Meal allowance
- Transportation voucher
- Food allowance
- Total Pass
- Birthday day off
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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