Over 17 years experienced in clinical research. Additionally, Cleomines Araujo has 4 year(s) of experience in the Contract Research Organization (CRO) Industry as a Clinical Research Associate I, II, Senior and Project Manager. Furthermore, Cleomines Araujo has 12 year(s) of experience as a pharma employee as Clinical Research Associate and Latam Trial Coordinator.Recognized for support 30% increase at the number in the medical evidence studies initiatives in two years running a project to integrate Real World Evidence (RWE) studies practices, Late Phase Research and Observational Research in Oncology to reach medical affairs innovative inLatin America.

Local Study Representative - Responsibilities from feasibility and site selection to study closure (including expected communication with stakeholders (ex.: MSL and Medical Team) and common issue scalation) to reach milestones, provide landscape and manage timelines expectation.

Leader and Leadership team in managing operations, improving business unit performance and efficiency, and by leading key Business Unit projects.Ensure scientific quality and timely, cost-effective project delivery while adhering to ethical requirements and responding to business needs.Define best practices relating to the integration of Real Word Evidence (RWE) studies practices and continuously improve internal processes and planning to capture RWE, Late Phase Research and/or Observational Research in Oncology and/or innovative medicines development and commercialization programs.Early Access Program management (compassionate use, expanded access, or named patient supply).Budget planning and budget management accountability including contract management and/or contract administration.Cross functional and/or collaboration work interaction with ClinOps, MSLs, Business Units, Mkt Access and HEOR (Health Economics and Outcomes Research), Legal, Procurement, Regulatory and more.Responsible for supporting by 300% increase at the number in the medical evidence studies initiatives in two years.Personal Skills:Analytical Skills, Communication Skills, Influence Outcomes, Marketplace and Industry Knowledge, Negotiating Skills, Organizational Skills, Planning Skills, Presentation Skills, Problem Solving Skills, Relationship Building Skills, Servicing Skills, Team Orientation, Vision and Direction, Microsoft Excel, Microsoft PowerPoint, Microsoft Project.

•Coordination of cross-project teams.•Collecting information on team performance against contract, customer expectations, and project baselines.•Serving as primary project contact with Sponsor•Development and overseeing of maintenance of internal databases and project plans.•Training and mentoring of junior project support staff

Responsible for the provision of clinical leadership and management to the immediate clinical team members.

I am accountable to provide an overall vision of the project goals and objectives to the team members. I have to detail schedules of activities, milestones, and deliverables of the project team, and identifies the resources available; I have to identify the roles and responsibilities of each member of the project team and to define the specific deliverables due from each team member, at each stage of the project; I have to establish the communication plan of the protocol, of procedures, and methods to communicate project information and issues among members of the team; I have to establish the forms and templates to simplify communication, record-keeping and reporting; I am accountable for risk analysis lists out potential problems and chances of deviance from the project methodology, the probability of such occurrences, the possible impact, and possible solutions.

I am responsible for writing the standards operations procedures (SOPs), to ensure compliance with these SOPs, to improve the rate of qualities standards and to maintain the compliance with ANVISA regulations, others applicable local regulations (as Federal Police, Environment Police), and GOOD TRANSPORTATION PRACTICE guidelines. I am responsible for introducing motivation programs, LEAN process, quality control programs and to ensure compliance with SOPs.

Acting as CRA in Local Clinical Studies (pre-study visits, regulatory/ethical process activities, investigator’s meeting organization, initiation, monitoring and closure visits) for Phase II, III and IV studies.

Report adverse event to global database and to the local health authority. Training for Customer Information Service, Sales Force and Company employees regarding Pharmacovigilance.Receipt of adverse event reports from customers and health care professionals via phone calls.

Provide information about medication intake, orientation about adverse events and the correct conduct in cases of overdose and intoxication to patients and healthcare professionals; Fill the adverse events source document; Performing and forwarding pharmacovigilance reports to pharmaceutical industries.