Brazil
1 month ago

Job Overview

Job Type
Full Time
Pay
Not disclosed

Job description

Location:
Brazil
Work arrangement:
On-site

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

08:00 to 17:00 Monday to Friday.

Responsibilities

We count on you to

  • Act as a technical reference on 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 assessments of the centers' performance 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 regulatory audits and 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 capacity building 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

  • Complete higher education in the health field.
  • Advanced English.
  • Deep command of Good Clinical Practices, Brazilian and international regulations, as well as experience in conducting and supporting audits.
  • Experience as a CRA, preferably with a history in multicenter and international studies.
  • Proven ability to act as a technical reference and conduct strategic study activities.
  • Strong experience with eClinical systems (EDC, CTMS, eTMF).

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;
  • Pharmacy Agreement;
  • Synvia Partnership Club (Educational, Language, Leisure and Culture Institutions);
  • SESC Partnership;
  • Physical health program - TotalPass;
  • Day Off – Health professional;

Childcare allowance (according to internal policy).

Role:
Full Clinical Research Monitor
Job Type:
Full Time

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