Clinical Research Manager

3 semanas atrás


Sao Paulo, Brasil MSD Tempo inteiro
**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.
This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
**Responsibilities include, but are not limited to**:
- Main Point of Contact for assigned protocols and link between Country Operations and Clinical Trial Team;
- Accountable for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out;
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to Clinical Research Associate Manager and/or functional vendor and internal management as needed;
- Performs Quality control visits as required;
- Leads local study teams to high performance: trains in the protocol other local roles, closely partners with and supports Clinical Research Associates as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinator, Clinical Research Associates and Clinical Operations Manager);
- Accountable for creating and executing local risk management plan for assigned studies;
- Identifies and shares best practices across clinical trials, countries, clusters;
- Promotes local and regional strategy development consistent with long‐term corporate needs;
- Partners internally with Headquarter functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials.
**Main Requirements**:
- Bachelor’s degree in Science or related area;
- Advanced degree, (e.g., Master degree, MD, PhD);
- Proficiency in written and spoken English and local language;
- Experience in Clinical Research necessary;
- Clinical Research Associate experience preferred;
- Experience in Project Management and site management;
- Strong organizational skills with demonstrated success required;
- Ability to make decisions independently and oversee important activities relevant to clinical research;
- Strong comprehension of local regulatory environment;
- Strong scientific and clinical research knowledge is required;
- Strong comprehension of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously;
- Experience functioning as a key link between Country Operations and Clinical Trial Teams;
- Communicates effectively and builds a partnership spirit in a remote/virtual environment and across countries, cultures and functions;
- Strong leadership skills;
- Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
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 o
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