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 Operations Manager to be based in South Korea.
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.
· PERFORMANCE & COMPLIANCE
for execution and oversight of local operational clinical trial activities in a
country for assigned protocols in compliance with ICH/GCP and country
regulations, Merck policies and procedures, quality standards and adverse event
reporting requirements internally and externally.
SUBMISSIONS & LOCAL LANGUAGE MATERIALS
for execution and oversight of clinical trial country submissions and approvals
for assigned protocols. Development of local language materials including local
language Informed Consents and translations. Interactions with IRB/IEC and
Regulatory Authority for assigned protocols.
& QUALITY OVERSIGHT
for managing country deliverables, timelines and results for assigned protocols
to meet country commitments. Responsible for quality and compliance in assigned
protocols in country. Contributes to the development of local SOPs. Oversees
CTCs as applicable.
and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure
country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
Collaborates closely with Regional Operations to align country timelines for
assigned protocols. Provides support and oversight to local vendors as
PROCESS OVERSIGHT Oversight and coordination of local processes. Clinical and ancillary
supplies management, im- and exporting requirements, supplies destruction,
local electronic/hard copy filing, archiving and retention requirements, and
insurance process management. Enters and updates country information in
clinical and finance systems.
임상 업무 시 한국 참여 결정부터 첫 임상 개시까지 필요한 start-up 담당이 주된 업무임
이 중 프로토콜/동의서 번역 검토/승인 및 식약처 제출/승인업무가 중요한 portion이고, local process SME (subject matter expert)로서 local activity의 expert역할 수행
· 임상 모니터링 업무 5년 이상 경력자,
CTA/IND (식약처 제출/승인) 경험이 있는 분 선호
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
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