Senior Clinical Research Monitor

Role Summary

To make up our team, we are looking for professionals who want to contribute to our mission of improving the lives of more and more people.

If you have an innovative profile, think outside the box, and enjoy working in a modern and dynamic environment, this position is for you.

Come with us and be part of this journey. #VemSer Synvia

Unit of work

Paulínia/SP - Home Office

Work Scale

Mon/Friday from 08: 00 to 17:00

Responsibilities

We count on you to

• Act as a technical reference in the project, supporting the planning and execution of monitoring strategies;
• Conduct monitoring of centers of high complexity, high recruitment or with a history of critical deviations;
• Carry out in-depth performance assessments of the centers and support the implementation of corrective and preventive actions;
• Collaborate with the Project Manager in defining, reviewing and monitoring the monitoring plan;
• Review monitoring reports from less experienced CRAs, ensuring standardization and quality;
• Prepare centers for audits and regulatory inspections (ANVISA, FDA, EMA), providing technical guidance;
• Identify operational risks and propose mitigation strategies to ensure adherence to deadlines, data quality and participant safety;
• Conduct technical training sessions, induction 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 area when necessary.

Requirements

What we look for

• Completed higher education in the health field (Pharmacy, Biomedicine, Nursing or related);
• Knowledge of ICH-GCP and applicable regulations;
• Initial experience or practical knowledge in clinical monitoring (on-site or remote);
• Familiarity with clinical systems (eCRF, CTMS, eTMF) will be considered an advantage;
• Exposure to Bioequivalence, PK/PD or Phase 1 studies is desirable;

Intermediate English (reading and writing, conversation desirable).

Benefits

What benefits we offer you

• Transport Voucher;
• Parking (depending on availability);
• Health Plan at no monthly cost to the employee, with co-participation in exams and consultations;
• Dental Plan with monthly payment co-participation;
• Life Insurance at no cost to the employee;
• Flexible food/meal voucher;
• SESC Partnership;
• Physical health program - TotalPass;
• Day Off – Health professional;

Childcare allowance (according to internal policy).