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Medical Officer, Advancing Rotavirus Vaccine

PATH, a US based international development organization with the mission to improve the health of people around the world by advancing health technologies, strengthening systems and encouraging healthy behaviors. PATH India has a country office in New Delhi with site offices in Hyderabad, Lucknow, Bhopal and Mumbai

The goal of PATH Advancing Rotavirus Vaccine (ARVAC) program is to accelerate the development of new Rotavirus vaccines that are safe, effective, affordable, and accessible to the developing and emerging world. In that context ARVAC is leading a large pivotal and multicentric efficacy trial in India in partnership with an Indian manufacturer, to evaluate the safety and efficacy of a new Rotavirus vaccine candidate, aiming for market authorization in India and subsequent WHO pre-qualification.

The Medical Officer (MO) will be the core member of a clinical operation team. He / she will supervise the operations and provide medical expertise in the preparation and conduct of the clinical trial and preparation of the regulatory file.Specific responsibilities include:

  • Develop clinical project documents such as clinical development plan, protocols, data collection systems, study manuals, study tools, etc. in coordination with all relevant project personnel and resources, advisors and Clinical Research Organization's (CROs).
  • Ensure preparation of all relevant clinical trial technical documents such as IND dossiers, trial study reports, formats for approvals etc. for submission to regulatory and health authorities for licensing approvals.
  • Ensure timely, accurate and comprehensive clinical trial information is available to Project Director at all times.
  • Oversee the ethical clearance and monitoring process with PATH's Institutional Review Board (IRB) and all other partner IRBs to assure that all clinical and demonstration studies are in compliance with the highest standards of ethical research.
  • Coordinate the safety monitoring & pharmacovigilance activities including contracting with an external service provider.
  • Participate in site preparations for the pivotal Phase 3 study, as per International Conference of Harmonization(ICH) Good Clinical Practice (GCP) standards.
  • Coordinate the setup and validation of the clinical immunology laboratory as per Good Laboratory Practice (GLP)standards.
  • Participate in monitoring activities between sites, field and laboratory, data entry and data management, auditing, and Data and Safety Monitoring Board (DSMB). Monitor progress of the studies and performance of sites, laboratory and Clinical Research Organization's (CRO) against scope of work, timing and budget. Ensure the study is conducted in accordance with Standard Operating Procedures (SOPs), legal requirements, and ICH guidelines.
  • Provide oversight of the assigned clinical trials to ensure that issues/concerns are identified and appropriate responses to such concerns are developed and executed.
  • Prepare all relevant clinical trial materials as per PATH requirements to ensure effective management, monitoring and evaluation of clinical trial activities.
  • Ensure and oversee proper documentation of the lessons learnt from field on demonstrable issues.
  • Participate in clinical trial contracting and budgeting process, as required, in close consultation with the Project Administrator.
  • Interface with all project personnel, partners, subcontractors and technical advisors to ensure clinical timelines are met, conflicts resolved and projects are on time and on budget.
Required Skills
  • Interpersonal skills and ability to work in a team. Capability to work within the existing organization and network. Capacities to interact with various experts.
  • Leadership, ability to supervise and coordinate activities.
  • Willingness to work in the field.
  • Excellent oral and written communication in English and ability to write clearly, logically and persuasively on medical matters for diverse audiences. Computer literacy.
  • Organized and able to handle multiple tasks.
  • Willingness to travel for up to 30% of time and work in the field.
  • Knowledge of Regulations and Guidelines related to clinical trials including GCO,ICH &Indian regulations.
  • Knowledge The Drug Controller General of India (DCGI) approval process.
  • Ability to analyze data,review reports.
Required Experience

M.D. degree and at least five years of experience in clinical research in industry, preferably in vaccine clinical trials and in community.Experience in working in teams,working in the field, preferably in multi center studies,experience with clinical trial documentation and in the preparation, performance, and reporting of clinical studies also required.

Job Location
New Delhi, INDIA

Medical Officer, Advancing Rotavirus Vaccine