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Last date of application: 10th June 2024

Work location: New Delhi

Vital Strategies India Services Private Limited is focused on strengthening and revitalizing public health systems through designing and supporting scalable solutions to leading causes of death, disease, and injury. In addition to our topical areas of focus – noncommunicable disease control, environmental health, and injury prevention, we also prioritize work that aims to strengthen the fundamental, foundational dimensions of public health practice that enable governments to tackle and respond to any public health challenge.

Scope of work

The Regulatory Consultant will be responsible for coordinating all submissions associated with approvals required for initiating a Phase 2b TB clinical trial (PARADIGM4TB).

All members of the Vital Strategies India team embody the organization’s values and are integral to promoting our brand, supporting our growth, and ensuring operational excellence.

Duties and Responsibilities

The overall responsibilities will include identifying all applicable local approvals required to initiate the trial in India, and coordinating the submissions required. 

  • Overseeing protocol submissions to Institutional Ethics Committees, Key national regulatory bodies (DCGI, ICMR) and coordinating with MRC-CTU (Medical Research Council-Clinical Trials Unit at University College London towards this.
    • Assisting key nodal clinical sites with online portal and submissions
    • Liaising between clinical sites and MRC-CTU for queries,
  • Supporting the preparation activities for undertaking the Trial.
  • Coordinating with various agencies to obtain all approvals required to commence the trial, including DCGI, ICMR, Clinical sites, and Vital Strategies.
  • Facilitating necessary regulatory approvals for the Trial.
  • Assisting in the development of budgets for the Trial.
  • Assisting in the development of contractual arrangements for the trial.
  • Assisting in the procurement of supplies/equipment related to the trial.
  • Assisting in the oversight of renovations at the site required to commence the trial.

Qualification and Experience

  • MBBS, MD or Master’s degree in a health discipline such as Biotechnology, Pharmacy, Public Health and others. PhD preferred.
  •  7-10 years’ experience in clinical trial management, including managing regulatory submission dossiers and liaisons with DCGI for phase 2b/3 clinical trials; experience registering with and managing the SUGAM portal is a plus.
  • Experience managing international (industry or academic) clinical trial (preferred)
  • Experience working in a pharmaceutical/CRO regulatory/ or study start-up unit (preferred)
  • Experience working on a clinical trial for TB (preferred)

Working Conditions and Physical Requirements:

  • Ability to collaborate flexibly with colleagues across time zones.

Additional Information:

  • This role is contingent upon contract approval.
  • This is a short-term consultancy assignment lasting for 11 months.
  • The monthly fee would be up to INR 2,00,000
  • This position requires the candidate to be based in New Delhi and be available to work from Vital Strategies India’s New Delhi office.

Important Note- How to apply:

Please submit your application via the link below:

https://forms.monday.com/forms/7e43c8f71857c58ce383482059d38385?r=use1

Experience
7-10 years
Work Level
Mid-Level
Employment Type
Full Time
Salary
up to INR 2,00,000/- pm
Vital Strategies India Services Private Limited
View profile
Industry
Health systems strengthening
Location
Delhi

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