PATH is an international nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. PATH’s mission is to improve health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviors.
PATH is seeking a Senior Program Officer (Clinical Trials) for Rotavirus vaccine development project based in New Delhi for a large pivotal and multi center 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 be responsible for supporting all aspects of assigned clinical trial(s) under the overall guidance of the Project Director and supervision of the Clinical Team Leader working closely with other project team members.
The core responsibilities for this position include the following:
- Coordinating clinical study set-up and follow-up study activities and implementation of clinical development plan, strategy and studies.
- Support in development of study tools, guidelines /standard operating procedures and training materials; management of clinical study material; and implementation of issue resolution plans.
- Follow-up with day to day operational activities with the CRO(s) and other external services providers / stakeholders.
- Participate in co-monitoring visits at sites as required.
- Administer, as needed, the protocol and related study training to site personnel.
- Be responsible for study document management and upkeep.
- Regularly evaluate the quality and integrity of the study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Update the clinical team leader on all the issues and coordinate resolution of such issues.
- Work with project officer to regularly update tracking systems in order to manage accuracy of information.
- Contribute, as needed, to the ongoing scientific review of the clinical trial data during the course of the trial.
- Any other applicable task as assigned
- Strong interpersonal skills.
- High level of computer proficiency in using Microsoft office,
- Excellent oral and written communication in English.
- Knowledge of clinical study outsourcing.
- Highly organized and able to handle multiple tasks.
- Willing and able to travel.
An ideal candidate would hold at minimum a Bachelor’s in pharmacy or biological sciences or equivalent with at least five years of experience in coordinating various functions (clinical operations, data management, safety surveillance, etc.). This experience should take place either at a pharmaceutical company or Clinical Research Organization including some experience in project leadership and thorough understanding of ICH Good Clinical Practices, clinical trials management, Clinical Safety Data Management, (including site monitoring) and regulatory compliance (including Indian regulations).
Senior Program Officer, Clinical Trials, India Country Program