Senior Clinical Research Monitor

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đŸ”„ 2 minutes ago

đŸ—ŁïžđŸ‡§đŸ‡·đŸ‡”đŸ‡č Portuguese Required

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Logo of SYNVIA

SYNVIA

51 - 200 employees

Founded 1993

📩 Logistics

🚗 Transport

đŸ€ B2B

Logistics ‱ Transport ‱ B2B

SYNVIA is a logistics and transport company specializing in secure, compliant, and customized supply chain solutions for high‑value and sensitive industries. The company provides multimodal transport (road, air, maritime), temperature‑controlled and regulated warehousing (including ICPE), handling of dangerous goods, customs transit services, and value‑added operations like co‑packing, labeling and kitting. SYNVIA focuses on B2B clients in sectors such as chemistry, energy, agriculture, cosmetics and public hygiene, emphasizing traceability, regulatory compliance, and operational agility.

📋 Description

‱ Serve as the technical reference for the project, supporting the planning and execution of monitoring strategies; ‱ Conduct monitoring of high-complexity sites, high-recruiting sites, or sites with a history of critical deviations; ‱ Perform in-depth assessments of site performance and support implementation of corrective and preventive actions; ‱ Collaborate with the Project Manager in defining, reviewing, and tracking the monitoring plan; ‱ Review monitoring reports from less-experienced CRAs, ensuring standardization and quality; ‱ Prepare sites for audits and regulatory inspections (ANVISA, FDA, EMA), providing technical guidance; ‱ Identify operational risks and propose mitigation strategies to ensure adherence to timelines, data quality, and participant safety; ‱ Conduct technical training sessions, initiation visits, and internal training activities for new CRAs; ‱ Support complementary study activities, such as eTMF review, regulatory support, and alignment with the sponsor on operational deliverables; ‱ Maintain senior-level communication with internal and external stakeholders, representing the monitoring function when required.

🎯 Requirements

‱ University degree in a health-related field (Pharmacy, Biomedicine, Nursing, or related disciplines); ‱ Knowledge of ICH-GCP and applicable regulations; ‱ Some initial experience or practical knowledge in clinical monitoring (on-site or remote); ‱ Familiarity with clinical systems (eCRF, CTMS, eTMF) is a plus; ‱ Exposure to Bioequivalence, PK/PD, or Phase I studies is desirable; ‱ Intermediate English (reading and writing; conversational skills desirable).

đŸ–ïž Benefits

‱ Transportation allowance (commuter benefit); ‱ Parking (subject to availability); ‱ Health insurance with no monthly premium for the employee, with co-payments for exams and consultations; ‱ Dental plan with employee co-payment; ‱ Life insurance provided at no cost to the employee; ‱ Flexible meal/food allowance; ‱ SESC partnership; ‱ Physical wellness program – TotalPass; ‱ Day off for health professionals; ‱ Childcare assistance (per internal policy).

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