Regulatory & Start-Up Manager (FSP)
Buenos Aires, Argentinien| Mexiko
Stellenbeschreibung
Reg & Start Up Manager – Sponsor Dedicated
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work and resources.
You will:
- Oversee the execution of Site Activation and Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
- Upon award, develop the site activation delivery strategy according to project scope and specifics, indicating the activation projection for sites in diverse countries within LATAM, regulatory, contract and start up elements’ timelines.
- Oversee the execution of site activation strategy, focusing in delivering sites in the agreed timeline, budget and within scope, pro-actively identifying and addressing risks.
- Communication with client, project team members and local regulatory specialists on study sites status, activation projections, risks, and opportunities to secure the activation strategy.
- Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems and client´s system, databases, tracking tools, timelines, and project plans with project specific information.
What do you need to have?
- Strong leadership competencies to lead projects and multi-cultural teams.
- Project ownership controlling delivery on time, within scope.
- Demonstrable experience working on multiple projects or clients balancing competing priorities.
- Strong communication skills with the ability to negotiate and challenge decisions.
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
- Proven ability to establish and maintain effective working relationships with co-workers, managers, and sponsors
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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