Clinical Trial Officer, Mekong Program

PATH, Hanoi, Vietnam

Skill Required:, Research and Analysis
Preferred Experience: 
3 to 10 Years
Closing Date for Applications: 
31st December, 2015

Job Description

Specific responsibilities include:

Provide technical support to local manufacturers (trial sponsor) and research institutions; and provincial, district and commune partners in implementation of phase II/III trials of H5N1 influenza vaccine and phase II, III trials of seasonal influenza vaccine, including:

  • preparation of clinical trial dossier for submission to local Institutional Review Board and regulatory authorities;
  • development of Standard Operating Procedures, Case Report Forms, Informed Consent Forms, diary cards and other related clinical training trial documents;
  • Building of research capacity for local researchers;
  • conduct of training on protocol, MOP, SOP for study team;
  • provision of technical supports for study team in conducting trial activities in the field;
  • update and handling of the trial master files for Sponsor and PATH;
  • Facilitation of the collaboration between sponsors, research institutions, local partners and Contract Research Organizations.
  • Build and maintain relationships with local partners.
  • Regularly update the Regional Technical Director, Vietnam Program Team Leader, Senior Clinical Trial Officer, Project Manager and US.
  • Other activities as required.

Required Skills

  • Demonstrated training and presentation skills;
  • Proven interpersonal skills and ability to work effectively in a team;
  • Excellent written and spoken Vietnamese and English.

Required Experience

  • Advanced degree in medicine or public health;
  • A minimum of 5 year work experience in clinical trial;
  • Experience working effectively with government counterpart;
  • Willingness and ability to travel within Vietnam up to 50 percent per year

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