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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 Clinical Project consultant will oversee all aspects of regulatory and study start-up services offered by Vital Strategies for Phase 2b TB clinical trial (PARADIGM 4TB). He/she will be the key focal point for communication with the Trial Sponsor, Medical Research Council-Clinical Trials Unit at University College London (MRC-CTU at UCL), prospective clinical sites participating in the trial in India, and other key national stakeholders such as the Central TB Division (CTD), the Indian Council for Medical Research (ICMR), and the Drug Controller Govt. of India (DCGI).

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 project management, and stakeholder engagement associated with commencing the trial in India, and in accordance with all relevant local regulations. 

  • Clinical/Site – Patient management and retention including follow-up for trial visits and procedures accounting for Covid-19 situation; Database Management including ensuring timely data entries and query resolution; Investigatory Site File (ISF) management; coordinating site monitoring visits with IQVIA for ISF review and source data verification; coordinating with MRC-CTU for data management.
    • Laboratory– Liaising with NDTBC for oversight of sample tracking and shipments; equipment calibration; and Laboratory Site File (LSF) management; coordinating with ITM for lab quality management and data management related matters.
    • Community Engagement – Representation in Community Advisory Board (CAB) to provide study updates and input into activities for TB patients/communities. 
    • Operational/Administrative – Coordination with office staff for procurement, and finance matters, including generating periodic milestone reports required for raising invoices.

Qualification and Experience

  •  A certification in Clinical Research would be a plus.
  • 10-12 years’ experience in project management with expertise in dealing with multiple partners such as government, non-government, and academic/research stakeholders.
  • Experience working on and dealing with TB projects /research stakeholders.
  • Experience working on and dealing with clinical trial regulators.

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/f64a73308388f5bcbfc3e77283697e7c?r=use1

Experience
10-12 years
Work Level
Mid-Level
Employment Type
Full Time
Salary
Upto INR 200,000/- pm
Vital Strategies India Services Private Limited
View profile
Industry
Health systems strengthening
Location
Delhi

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