TMF Specialist Leader for Clinical Research

Há 2 dias


São Paulo, São Paulo, Brasil ICON Strategic Solutions Tempo inteiro

As a Lead TMF Specialist, you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.

Company Overview

Our organization is dedicated to delivering high-quality services that meet the needs of our clients. We are committed to innovation, excellence, and teamwork in everything we do.

With a strong focus on customer satisfaction, we strive to provide tailored solutions that exceed expectations.

Job Description

As a Lead TMF Specialist, you will be responsible for independently maintaining Trial Master Files for assigned studies. This will involve participating in end-to-end TMF management activities, including adherence to organizational TMF standards and study-level quality control reviews.

You will also facilitate issue resolution, prioritize work accordingly to meet departmental needs, and meet deadlines with some supervision.

In addition, you will participate in inspection readiness reviews, preparation activities, and inspection conduct.

Furthermore, you will provide guidance and training as applicable to TMF stakeholders and serve as a resource to colleagues on more advanced TMF activities.

Required Skills and Qualifications

To be successful in this role, you must have a Bachelor's degree in a relevant discipline.

Effective communication and coordination skills are essential, as well as experience working in a TMF platform and CTMS platform.

Strong critical thinking skills with a focus on inspection readiness are also required.

Benefits

We offer a competitive salary of $80,000 per year, plus a range of additional benefits designed to support your well-being and work-life balance.

Our benefits package includes health insurance, retirement planning, and paid time off.

We are committed to providing an inclusive and accessible environment for all employees.

We are an equal opportunities employer and welcome applications from diverse candidates.



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