Clinical Trial Officer, Mekong Program
PATH, Hanoi, Vietnam
Closing Date for Applications:
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.
- Demonstrated training and presentation skills;
- Proven interpersonal skills and ability to work effectively in a team;
- Excellent written and spoken Vietnamese and English.
- 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