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CHAIRMAN ASSISTANT

...

CLINICAL RESEARCH PROJECT MANAGER/ ASSOCIATE (1 Project Manager ; 2 CRAs)

 At Nanogen, all clinical trials are running according to the Principles of Good Clinical Practice (GCP) of ICH (International conference o­n Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use) or GCP of WHO (World Health Organization). Additionally, they must be approved by National Regulatory authorities and Ethics Committees. These boards ensure that proposed trials are acceptable and all participants are fully aware of benefits and risks related to the trial. Healthcare professional, or investigators, who conduct the trials must take appropriate actions to protect patients from any potential harms.

During the phases of trials, Nanogen takes evaluation of the benefit-risk portfolio of new medicine. If the risks exceed patients’ benefits, Nanogen will adjust the protocol or halt the study for that medicine.

Furthermore, Nanogen has taken several important steps to ensure that information about clinical trial results reach the public in a timely and balanced manner.

 

Job description

  1. General areas of responsibility include: Study team liaison, project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communication between project team, study team, contract and financial management.
  2. Primary Role
  • Oversee and coordinate and development and trial projects
  • Guide, facilitate and supervise the clinical project team
  • Develop budgets, time lines, and quality guidelines for projects. Plan, track and re-forecast issues to maintain effective control against the approved budget and time-lines
  • Pro-actively works with others departments, reporting project progress and make recommendations to align with therapeutic and organizational strategies.
  • Guide the selection and management of clinical research organizations. Coordinate the delivery of clinical trial supplies
  • Compile and drive documentation for the project, ensuring the accuracy and quality of regulatory data

 

Requirements

  • Qualifications:

-Degree in biomedical discipline (Medical Doctor, MSc in Pharmacy, Public Health or related fields)

-Proficiency in English; Microsoft Word, Excel and Power Point.

  • Experience:

-Experience in using Microsoft Office applications, including Word and Excel.

-Minimum of 1-2 years experience in conducting, coordinating or monitoring of clinical research

  • Knowledge:

-Vietnamese Pharmaceutical Industry

-Excellent scientific knowledge

  • Competencies:

-Willing to work a flexible schedule

-Excellent in computer skills

-Excellent in English written and communication

-Ability to work under pressure and timeframes and different projects

-Strong team player and training ability

-Ability to communicate effectively with local medical community

-Willing/comfort with travelling when necessary.

 

Candidates should clarify the position applied in their CVs. Based on candidates’ experience and abilities, he/she will be considered for that position.


Please send your CV to:

Nanogen Biopharmaceutical

Lô 1 – 5C, Khu Công Nghệ Cao – Phường Tăng Nhơn Phú A – Q.9

Tel: (+84) 08. 3 730 9931 – 08. 3 730 9945 (122)

or

Email: contact@nanogenpharma.com


诚征中文翻译人员一名

工作内容:

  • 中文翻译:现场,文件
  • 协助联络客户,市场调查
  • 协助销售活动规划与执行

工作条件:

学历要求:       专科,大学毕业

科系要求:       不拘

语言条件:       中文(听,说,读,写流利),具英文者佳。

擅长工具:       电脑(OFFICE作业系统,EMAIL…)

工作技能:       不拘

其他条件:       具自主管理,独立作业

                   溝通協調能力、高度責任心、開朗親和力佳与跨领域合作能力

薪资:            面议

应征方式:     

联络人:Ms. Thúy Diễm

应征者请自备有照片覆历一份,寄到 thuydiem@nanogenpharma.com

Medical advisor

Duties and Responsibilities

Provides medical support to Marketing division ,representatives & customers

Act as a medical resource to the company as a whole and particularly to the clinical research department (protocol and CRF writing, adverse events, discussions with investigators, internal meetings)

Work with the research staff at sites to ensure that the study is executed in compliance with the protocol and applicable local and international regulatory standards, which will involve visiting the study sites on a regular basis

Coordinate all regulatory, logistical, training and reporting tasks associated with running a research study including:

  • Implement required training for research staff, particularly in the areas of human subjects protection, protocol related procedures, community engagement activities, laboratory processes, data collection and good clinical practice.
  • Design standard procedures for study related activities including laboratory, clinical and data management processes.
  • Create and verify the completion of tracking forms to record study procedures.
  • Ensure that required ethical reviews, contracts and regulatory approvals are obtained.
  • Plan, implement and coordinate all aspects of data collection, recording and source documentation, as per hospital and unit policy and ICH/GCP guidelines.
  • Achieve recruitment targets and address operational issued.
  • Track study progress, identify and resolve problems in ability. Report to stakeholders as required.
  • Execute study-related administrative tasks, such as collection of data and regulatory documents, managing reimbursement for patients and study staff, filing or retrieving files, maintaining patient charts and supply inventories, etc…

Liaise with colleagues in monitoring, data management and laboratory departments to ensure quality and harmonious execution of study procedures.

Be a part of a team that provides training for senior hospital staff on the ICH guidelines of Good Clinical Practice. 

Translate the medical documents, the package inserts and report writing.  Coordinates report and protocol-writing activities.

Job Requirement

Essential Criteria:

• Graduated from Medical University.

• High level of organizational and record keeping skills.

• Proven oral and written presentation skills. 

• Excellent Vietnamese and English language skills.

•Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System, Electronic Documents Management System, MS-Office products such as Excel and Word

Desirable Criteria:

• Work experience of a Health Research Institution 

• Experience conducting or managing clinical research

• Experience working in an international organization / environment

• Experience of working in a pharmaceutical/scientific environment

 

Contact:            Dr. Phuong Thuy

             Email: phuongthuy@nanogenpharma.com

IF YOU WANT TO JOIN OUR TEAM AND PARTICIPATE IN OUR SUCCESS, PLEASE SUBMIT YOUR APPLICATION.




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Or send us your application to

Nanogen Biopharmaceutical Co.

Address: Lot I – 5C Saigon Hitech Park,
Tang Nhon Phu A Ward,
Dist.9, Ho Chi Minh City,
VIETNAM

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