**Job Description**:
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.
Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
**Main responsibilities**
- The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the Clinical Research Associate Manager, the person ensures compliance of study conduct with International Conference on Harmonisation Good Clinical Practice and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally;
- Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites;
- Actively develops and expands the territory for clinical research, finding and developing new sites;
- Participates in internal meetings and workstreams as Subject Matter Expert for monitoring processes and systems.
**Main requirements**
- Bachelor's degree with strong emphasis in science (pharmacy/biology);
- Solid experience of direct site management (monitoring) experience in a bio/pharma/Clinical Research Organization.
- Fluent in Portuguese and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively;
- Good understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonisation Good Clinical Practice & country clinical research law & guidelines.
- Hands on knowledge of Good Documentation Practices
- Proven Skills in Site Management including management of site performance and patient recruitment;
- Demonstrated high level of monitoring skill with independent professional judgment;
- Ability to understand and analyse data/metrics and act appropriately.
We are a research-driven biopharmaceutical company.
Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world.
We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
**Who we are**
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.
For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.
Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
**What we look for**
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world.
Here, you have that opportunity.
You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.
Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
**We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
**
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**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R225041