Clinical Trial Officer

Clinical Trial Officer, Chemistry, manufacturing, & control (CMC) technical support for Inluenza Vaccine Manufacturers, Mekong Regional Program
Tracking Code: 6774

Job Description

Please note: Vietnamese nationals are encouraged to apply.

Please submit a cover letter with your resume describing your interest in this position and how you meet the requirements. Application materials must be submitted in English and applicants must have legal authorization to work in Vietnam to be considered and confirm this in their cover letter. PATH offers a highly dynamic work environment and provides competitive compensation and benefits based on experience. Salary and benefit package are paid in VND.

PATH is an international organization that drives transformative innovation to save lives and improve health, especially among women and children. We accelerate innovation across five platforms—vaccines, drugs, diagnostics, devices, and system and service innovations—that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health. Working in Vietnam since the early 1980s, PATH established a permanent office in Hanoi in 1997 and an office in Ho Chi Minh City in 2014.

PATH seeks a Clinical Trial Officer to provide technical support for local research institutions, partners and field site teams in the implementation of influenza vaccine clinical trials. The overall goal of the project is to build regionally-based, independent and sustainable influenza vaccine production capacity in Vietnam.

Under the guidance, and support from Regional Technical Director, Senior Clinical Trial Officer, Project Manager and US based PATH staff, and support and supervision of the Vietnam Program Team Leader, specific responsibilities include:

Duties and Responsibilities:

• Provide technical support to local manufacturers and research institutions; and provincial, district and commune partners in implementation of phase II/III trials of H5N1 influenza vaccine and phase I, II, III trials of seasonal influenza vaccine, including:
  
  • preparation of clinical trial dossier for submission to local Institutional Review Board authorities;
  • development of Standard Operating Procedures, Case Report Forms, Information Consent Forms, diary cards and other related clinical training trial documents;
  • capacity building of local researchers;
  • facilitating 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;
• Willingness and ability to travel within Vietnam up to 50 percent per year.

Required Experience

• Advanced degree in medicine or public health;
• A minimum of 5 year work experience in vaccine and immunization;
• Experience working effectively with government counterparts;
• Experienced working in vaccine clinical trial.

Job Location: Hanoi, Vietnam

Company Location: Vietnam, Hanoi

Position Type: Full-Time/Regular

Apply: www.path.org