Join us in our mission to INVENT the future. Let’s be part of our team of dedicated, energetic individuals who are committed to be the most trusted supplier of pharmaceuticals and health products worldwide. Apply now as Clinical Research Manager to be based in South Korea.
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
Accountable for performance and compliance 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.
Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local loles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated).
Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed.
EXTERNAL CUSTOMER FACING
Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country point of contact for programmatically outsourced trials for assigned protocols.
INTERNAL COLLABORATION & STRATEGY
Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with Regional Operations.
한국의 규정, ICH/GCP, company compliance에 맞게, 해당 임상업무과제를 진행
담당 과제의 deliverable/timelines/results을 달성하기 위해, 본사 과제 담당자와 긴밀하게 협업하고 proactively 이슈 해결함.
부서 내 과제 담당자(COM, CRA, CTC) 업무를 oversees 하면서, 해당 임상업무의 Performance 및 quality/compliance를 ensure 함
Outsourcing vendor, 연구자, 기타 다른 외부 stakeholder들과 협력을 통화 external customer facing 역할
임상업무 약 6-10년 이상 경력자로, monitoring, project manager, people manager, quality manager 등의 경험이 있는 분
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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 for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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위 Workday 시스템으로 5월20일(수)까지 지원자를 받습니다.