**Job Description**: The **Clinical Research Manager **role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The **Clinical Research Manager** could be responsible for a particular study for several countries in a cluster. **Responsibilities include, but are not limited to**: - Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). - Responsible 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. - Accountable for performance for assigned protocols in a country in compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. 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 collaborates with and supports Clinical Research Associates as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration - Responsible for creating and executing a local risk management plan for assigned studies. **Experience Requirements**: - Bachelor degree in Science - 5-6 years of experience in clinical research - Fluent Spanish 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 GCP/ICH & country clinical research law & guidelines. - Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. - Knowledge in Project Management and site management. - Strong organizational skills with demonstrated success required. - Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head /CRD - Requires strong understanding of local regulatory environment - Strong scientific and clinical research knowledge is required - Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. **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.** **Search Firm Representatives Please Read Carefully** **Employee Status**: Project Temps (Fixed Term) **Relocation**: No relocation **VISA Sponsorship**: **Travel Requirements**: **Flexible Work Arrangements**: **Shift**: **Valid Driving License**: **Hazardous Material(s)**: **Number of Openings**: 1 **Requisition ID**:R224275