Clinical Research Monitor, Junior

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🕒 June 26

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SYNVIA

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

📦 Logistics

🚗 Transport

🤝 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

• Conduct monitoring visits (Site Qualification Visit – SQV, Site Initiation Visit – SIV, Interim Monitoring Visit – IMV, and Close-Out Visit – COV) according to the monitoring plan. • Perform on-site and/or remote monitoring, ensuring the study is conducted in accordance with the protocol, ICH-GCP, SOPs, and local regulations. • Verify source data (SDV/SDR) and ensure the quality, integrity, and traceability of clinical data. • Identify protocol deviations, inconsistencies, and operational risks, supporting the implementation of corrective and preventive actions (CAPA). • Work on clinical studies including Bioequivalence, Pharmacokinetics (PK), Pharmacodynamics (PD), and Phase I studies, paying attention to the operational particularities of these designs. • Ensure that sites are adequately trained on the protocol, study procedures, and systems used (eCRF, IWRS, eTMF). • Review and monitor eCRF completion, and support query resolution with sites. • Ensure proper management of the Investigational Product (IP), including storage, dispensing, accountability, and reconciliation. • Keep the TMF/ISF up to date, ensuring completeness and document compliance. • Develop and maintain professional relationships with investigators and site teams. • Proactively communicate study status, risks, and issues to the Project Manager and other stakeholders. • Prepare monitoring reports and associated documentation within expected deadlines and quality standards. • Support start-up processes (when applicable), including collection of regulatory documents and site feasibility. • Provide support during audits and regulatory inspections.

🎯 Requirements

• Bachelor's degree in a health-related field (Pharmacy, Biomedicine, Nursing, or related disciplines) • Knowledge of ICH-GCP and applicable regulations • Entry-level 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)

🏖️ Benefits

• Transportation allowance • Parking (subject to availability) • Health plan with no monthly premium for the employee, with co-pay for exams and consultations • Dental plan with employee co-pay • Life insurance at no cost to the employee • Flexible meal/food allowance • Pharmacy discount program • SESC partnership • Physical wellness program - TotalPass • Day off – Health professional • Childcare assistance (per internal policy)