The World Bank is looking to hire a short-term consultant (STC) to:
BIRAC has already selected a few grantees developing products that will need to undergo clinical trials. It is expected that two to three grantees will apply for, receive regulatory approval, and/or start clinical trials by the first half of the 2019 calendar year.
For each clinical trial, the consultant will:
To conduct this work, the consultant is expected to visit the sponsor/CRO for each clinical trial at least twice (one visit for each stage above).
While the CRVMF builds on standard legal and regulatory framework for clinical trials in India, which are not under the purview of BIRAC but rather under that of the appropriate regulatory authorities, it also establishes requirements for i) BIRAC oversight for clinical trial management ii) a program-based grievance redressal mechanism and iii) capacity building and technical assistance relating to the CRVMF.
The consultant will:
The deliverables will be i) and initial report assessing the sponsor/CRO’s systems and highlighting any gaps to be addressed; ii) For clinical trials in the implementation phase, a follow up report assessing the trials’ compliance with SOPs and ETDs during implementation
The deliverable will be a report assessing existing mechanisms for compliance with the CRVMF, highlighting gaps, if any, and providing recommendations for improvement.
The ideal candidate will have the following qualifications:
TIMING, LEVEL OF EFFORT, AND ACCOUNTABILITY
The STC will be hired for a period of (30) days beginning January 1st, 2019 and ending June 30th, 2019, to be extended as needed, contingent on acceptable performance and after agreement by both parties.
The Consultant will work both on and offsite with a minimum of two visits to India over the period (an initial 10-days mission is envisaged in first half of January).
The consultant will report to the World Bank and work closely with the BIRAC team.
Fees will be commensurate with experience and qualifications as per WBG rules.
For further information, please contact Robert Oelrichs - email: email@example.com