Clinical Study Start-Up Lead

IQVIA; Bogotá; Presencial; COP 90.000.000 - 150.000.000; Jornada completa

Descripción de la vacante

IQVIA Colombia seeks an experienced project/regulatory professional to direct site activation and maintenance activities for selected clinical studies. You will lead cross-functional teams, manage timelines and budgets, and ensure regulatory compliance across multi-regional programs.

The role involves developing and maintaining plans, coordinating with Regulatory & Site Activation teams, and delivering required documentation to support study initiation and ongoing maintenance.

Responsabilidades

• Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
• Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
• Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations

Descripción del empleo

IQVIA Colombia seeks an experienced project/regulatory professional to direct site activation and maintenance activities for selected clinical studies. You will lead cross-functional teams, manage timelines and budgets, and ensure regulatory compliance across multi-regional programs.

The role involves developing and maintaining plans, coordinating with Regulatory & Site Activation teams, and delivering required documentation to support study initiation and ongoing maintenance.