To be considered for this position, applicants must have the legal authority to work and reside in India.
PATH is an international nonprofit organization with the mission to improve the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviors. In India, PATH has a country office in New Delhi with site offices in Bhopal, Hyderabad, Lucknow, and Mumbai. In collaboration with PATH’s global programs, PATH in India has developed a diverse portfolio of public health programming in the fields of immunization, infectious and vector borne diseases, health technology commercialization, vaccine research and introduction, HIV and sexual and reproductive health, and maternal and newborn health.
PATH’s portfolio in vaccine development in India covers a range of new vaccine initiatives for malaria, rotavirus, meningitis, and pneumococcus with the objective of advancing development and introduction of affordable, safe and efficacious vaccines for the developing world
PATH is seeking a Program Officer (Clinical Trials) for Rotavirus vaccine development based in New Delhi for a large pivotal and multicentre efficacy trial in India in partnership with an Indian manufacturer, to evaluate the safety and efficacy of a new Rotavirus vaccine candidate. As a core member of project’s clinical operations team, the incumbent will assist the Project Director and work closely with other project team members.
Responsibilities:
PATH is an international nonprofit organization with the mission to improve the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviors. In India, PATH has a country office in New Delhi with site offices in Bhopal, Hyderabad, Lucknow, and Mumbai. In collaboration with PATH’s global programs, PATH in India has developed a diverse portfolio of public health programming in the fields of immunization, infectious and vector borne diseases, health technology commercialization, vaccine research and introduction, HIV and sexual and reproductive health, and maternal and newborn health.
PATH’s portfolio in vaccine development in India covers a range of new vaccine initiatives for malaria, rotavirus, meningitis, and pneumococcus with the objective of advancing development and introduction of affordable, safe and efficacious vaccines for the developing world
PATH is seeking a Program Officer (Clinical Trials) for Rotavirus vaccine development based in New Delhi for a large pivotal and multicentre efficacy trial in India in partnership with an Indian manufacturer, to evaluate the safety and efficacy of a new Rotavirus vaccine candidate. As a core member of project’s clinical operations team, the incumbent will assist the Project Director and work closely with other project team members.
Responsibilities:
- Responsible for preparing the clinical project planning (Gantt charts) and updating the plan on a regular basis for ongoing tracking and review of study progress using project management tools such as MS-Project under the direction of Project Director.
- Responsible for ensuring timely, accurate and comprehensive clinical trial information available to Project Director and Director at all times
- Responsible for coordinating information collection, compilation, editing and preparation of trial updates as required in coordination with the clinical operations team.
- Responsible for supporting all aspects of the clinical trial(s), as needed including coordination with the central laboratory,
- Support in the follow-up with day to day operational activities with the Contract Research Organization(s) (CROs) and Data Management.
- Assist, as needed, in the ethical clearance and monitoring process for PATH and all other partner IRBs to assure that all clinical and demonstration studies are in compliance with the standards of ethical research.
- Provide support, as needed, with regulatory and clinical trial documentation
- Ensure proper documentation of the lessons learnt from field on demonstrable issues.
- Other tasks as assigned
Required skills:
- Experience in clinical trial.
- Experience in project management.
- Strong interpersonal skills commensurate with the need to work closely with COM team, physicians, vendors/consultants, team members and numerous collaborators.
- High level of computer proficiency in using Microsoft office including project management tools such as Microsoft Project.
- Excellent oral and written communication in English.
- Knowledge of clinical study outsourcing
- Knowledge and experience of contracting with external service providers.
- Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including site monitoring) and regulatory compliance (including Indian regulations)
- Highly organized and able to handle multiple tasks.
- Willing and able to travel.
Required Experience
A Bachelor’s in pharmacy or biological sciences, or equivalen,t with at least five years of experience in a project leadership / supervisory role with involvement in coordinating various functions (clinical operations, data management, safety surveillance, etc.) either at a pharmaceutical company or CRO.
Job Location
New Delhi, INDIA
Position Type
Full-Time/Regular