Senior Clinical Trial Officer

Senior Clinical Trial Officer, Vaccines and Immunization Team, Mekong Program
Tracking Code: 6421

Job Description

Please submit a cover letter with your resume in one document 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.

NOTE: You are required to be a citizen of Vietnam to apply for this position. We WILL NOT respond to your application if you do not meet this requirement.

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. Our Vietnam Country Office responds to community health needs working in such areas as reproductive, maternal, and child health, TB, HIV, vaccines and immunization, emerging and epidemic diseases, and health technologies. To achieve impact, we work across the public and private sectors and focus on sustainable, system-level changes.

PATH seeks a Senior Clinical Trial Officer manage day-to-day activities, monitor all aspects of influenza vaccine clinical trials from PATH side and provide intensive technical support for local research institutions who implement clinical trials. The overall goal of the project is to build regionally-based, independent and sustainable influenza vaccine production capacity in Vietnam. The Senior Clinical Trial Officer will work closely with international and national PATH staff, country collaborators (vaccine manufacturers, research institutions and other related agencies) and will manage the clinical trial research team in Vietnam. Duties and responsibilities include:

- Support clinical trial design in collaboration with U.S based staff;
- Lead the clinical trial team at PATH in working with local partners in implementation of clinical trial activities;
- With guidance and support from Senior Team Leader, Deputy Program Director, Project Manager and US based PATH staff, provides technical support to local manufacturers and local research institutions in implementation of phase II/III trials of H5N1 influenza vaccine and phase I trial of seasonal influenza vaccine including:

• preparation of clinical trial dossier for submission to local IRBs, authorities
• development of SOPs, CRFs, ICFs, diary cards and other related clinical training trial documents
• training for local researchers
• providing day to day support to local partners during implementation of clinical trial activities in the field
• coordinating data management and clinical trial monitoring between clinical team at PATH, CROs, local and international partners
• support to local partners in preparation of clinical scientific report (in Vietnamese) for submission to local IRB and authorities

- Build and maintain relationships with local partners;
- Work closely with Project Manager to coordinate clinical trial activities with other project activities;
- Keep Senior Team Leader, Deputy Program Director, Project Manager and US team updated on a regular basis regarding the progress of clinical trial activities.

Required Skills

• Advanced degree in medicine or public health;
• Demonstrated report writing and presentation skills;
• Demonstrated leadership qualities at mid-management level;
• 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 30-40 percent per year.

Required Experience

• A minimum of 5 year intensive work experience in clinical trials;
• A minimum of 5 year work experience in vaccine and immunization;
• Experience working effectively with government counterparts;
• A minimum of 5 years progressive work responsibility with project management experience;
• Experience working with private sector a plus.

Job Location: Hanoi, Vietnam
Company Location: Vietnam, Hanoi
Position Type: Full-Time/Regular