.Location: BrazilWho We AreScience as a tool. People as inspiration. Intrials is a disruptive company with all the attributes that a CRO must master. We mix innovative projects with the necessary skills to provide a full service. Nothing stops us in the search for knowledge. Transforming people's lives through science tackling the challenges of our clients' projects in a focused and exclusive fashion.People are indeed our main asset. We work tirelessly to pilot and monitor Clinical Research projects since the beginning. We guarantee connection, innovation, and security in solutions for the entire health chain. Diversity & Inclusion are essentialto continue building our history of innovation. Diversity of color, belief, sexual orientation, religion, or any other characteristic are very welcome in all open positions at our company. It is a fundamental part of Intrials to constantly think and implement actions that reinforce the importance of good coexistence with all the people who are part of our DNA and together, to leverage and build true impactful results in our society.All about people, purpose and science.Primary responsibilities include, but are not limited to:Management of the Regulatory & Study Start-up team in all aspects; Define metrics and KPIs for the Regulatory & Study Start-up department; Prepare and maintain financial projections (forecasts) and monitor results; Prepare and maintain resources projections (forecasts); Define staff allocation for regulatory, start-up and logistics activities to PMs, and discuss allocation with PMs; Provide support/ mentoring / coaching / training to the Regulatory & Study Start-up team involved in the clinical trials; Ensure that Regulatory & Study Start-up team conducts clinical trials in accordance with the ICH-GCP guidelines, local and international regulations as well as following Intrials' and Sponsor's SOPs, as applicable; Ensure the clinical trials regulatory, start-up and logistic activities follow the forecasted activities, timelines, milestones and contract budget; Contribute to define strategies with COO; Participate in RFPs development and attend at bid defense meetings, if required; Act as Intrialsgovernance point of communication for the Sponsor during project development and conduction; Might act as the point of contact with sponsor during project development for regulatory, start-up and logistics procedures (but might only be aligned with the Lead CRAs and/or Project Managers); Might be responsible for the definition of regulatory, start-up and logistics strategies with sponsors, aligned with the Lead CRAs and/or Project Managers
