Location: Brazil Who We Are Science 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 essential to 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 Intrials governance 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. Primary activities include, but are not limited to: Check regularly the study metrics and milestones to guarantee that the projects are being conducted according to the Sponsor requirements; Keep regular contact with PMs, RSAs, COM, and BDM; Organize / conduct department meetings with study teams at regular basis and whenever needed; Conduct regular one to one meetings and performance evaluation; Oversee the Clinical Trials regulatory and start-up activities; Oversee the Clinical Trials importation and logistic activities; Oversee study safety reports management, when applicable; Analyze and anticipate risks - ensure they are mitigated with robust action plans in place as agreed with PM, QAM, COM and / or the Sponsor; Provide support to PMs on regulatory, start-up and logistics activities and strategies, when required; Assist in the creation and revision of the SOPs related to the department activities; Support team during Audits and CAPAs; Assist PM to prepare project revenue and forecast activities in the project financial control; Analyze risks and anticipate/identify potential problems; ensure they are mitigated/solved with robust action plans in place as agreed with PM, QAM and / or Sponsor; Shares lessons learned and ensures adequate deployment of possible identified action plans for local and region improvement; Provide training, feedback, and support for Regulatory & Study Start-up team in Latin America; Sites, sponsors, brokers, and regulatory agencies communication for problem resolution; Build strategies with board of directors; Support Business Development department on regulatory knowledge for RFPs, contract updates and bid defense meetings; Perform interviews and staff hiring; Prepare and control department's budget. Participate in local and / or international meetings / courses in order to improve / acquire new skills. Requirements: Degree in the health science area or equivalent (Pharmacist, Biology, Biomedicine, Nursing, Medicine, other); Solid experience working in Clinical Trials Regulatory or other areas in Pharmaceutical companies, clinical sites or CROs; Strong Knowledge of Clinical Trials regulations from Brazil and Advanced knowledge of Clinical Trials regulations from other countries in Latin America where Intrials has offices; Computer skills on Windows environment and Microsoft Office tools; Fluent in English; Spanish is highly recommended; Formal training or Project Management degree will be considered a plus.
