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Senior Clinical Research Associate (

Hoffmann-la Roche Ltd., Representative Office In Vietnam 26th Floor, Bitexco Financial Tower, 2 Hai Trieu Strt., Dist 1, HCMC

Nơi làm việc: Hồ Chí Minh

726 lượt xem
Đăng tuyển 12 ngày trước

các phúc lợi dành cho bạn

Roche annual performance bonus
Premium healthcare plan for you and your family
Training opportunities

Bạn Nên Có Kỹ Năng

Clinical Data Management
Clinical Trial
Clinical Research

Bạn Sẽ Làm Gì

Responsible for providing coordination and support to all clinical operation team to ensure achievement of study goals, as well as tracking and maintaining study logistic information, systems and tools and appropriate study documentation in order to improve and maintain the quality and effectiveness of processes and activities in clinical operation in accordance with ICH GCP (Good Clinical Practice), local regulations, timelines and Company’s Standard Operating Procedure (SOP)
Conducting activities related to start-up, on-going and close down phase. Including delivering training, site management, monitoring and support
Ensuring management of invoices and payments including assisting as well as maintaining study payment trackers in Quantum
Reconciling and tracking essential documents for the country level Trial Master File (paper or electronic) according to ICH-GCP and Roche procedures. This may include collection/retention/reconciliation of regulatory and investigator documentation, safety reconciliation, drug and non-drug reconciliation
Ensuring documentation and archiving for all clinical study documents as per required in ICH –GCP, Roche SOP and Local Regulations
Organizing and coordinating the logistic of internal and external meetings. These includes team meeting and external meeting, Investigator meetings
Becoming co-monitor, as required and with appropriate oversight and training, during high volumes periods (eg. initiation visit, document reconciliation at study close-out) or when appropriate, to alleviate back logs in study workload which could potentially have a negative impact in achieving project
Developing and maintaining functional knowledge of GCPs, Roche SOP and Local Regulations and therapeutic area (s) through continued training provided by APT or other function to ensure patient safety and data integrity.

Chuyên Môn Của Bạn

Possess Life Science or Pharmacies Educational background (Bachelor degree or Diploma /D3 with considerable experience)
3 year experience in similar position
Demonstrate a self-driven person, autonomous, eager to learn and creative attitude
Show excellent communication, inter-personal skills, and personal influence
Proficient in operating Microsoft Office
Good command of English

Về Công Ty Chúng Tôi

Hoffmann-la Roche Ltd., Representative Office In Vietnam 26th Floor, Bitexco Financial Tower, 2 Hai Trieu Strt., Dist 1, HCMC

Qui mô công ty: 100-499

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics.
Roche is the world’s largest biotech company with truly differentiated medicines in oncology, infectious disease, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.
Currently, Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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