MANAGER, CLINICAL OPERATIONS (CRA LINE MANAGER), BRAZIL - IQVIA BIOTECHUnleash Your Potential. It takes curiosity and intellectual courage to accomplish great things.It takes brave minds to bring powerful ideas to reality and transform healthcare.We are a diverse, global team that shares a passion for collaboration and solving complex problems.Together, we help customers drive healthcare forward.Join IQVIA and see where your skills can take you.Basic Functions: Works with Clinical Operations Management staff to ensure the successful management, performance, and career development of Lead Clinical Research Associates (CRAs) and Clinical Research Associates (CRAs).Provides training and consultation related to clinical operating activities in the conduct of clinical trial projects.Serves as a source of clinical research expertise for IQVIA Biotech clinical staff.Contributes to, and participates in, the marketing of IQVIA Biotech services.Assures compliance with Good Clinical Practices (GCPs), ICH, Standard Operating Procedures (SOPs), Working Practices (WPs), and policies and procedures set forth by IQVIA Biotech and its clients.Essential Job Functions, Duties and Responsibilities:Line management for assigned Lead CRAs and CRAs (both office and regionally based).Plans career development of staff.Anticipates resource issues and plans remedial action.Communicates with the CTMs and/or Lead CRA, as needed, to ensure correct monitoring resources per project.Liaise with Project Managers to ensure monitoring deliverables/targets are met.Ensures any project issues and results of discussions with Project Managers are escalated appropriately.In coordination with the Director, Clinical Operations ensures proper allocation of Operations resources.Assesses training requirements for monitoring staff.Organizes appropriate training in liaison with the IQVIA Biotech e-process and Integration (Training) Department.Conducts field evaluation visits with staff at sites.Holds regular one-on-one meetings with staff to discuss performance.Writes and delivers performance appraisals.Reviews and approves time sheets and expense reports as required.Coaches, trains, and supports direct reports.Provides staff with expert clinical research and therapeutic advice.Assists with organizing and conducting Lead CRA, CTM and CRA Staff Meetings at regular intervals.Maintains awareness of company policies to effectively represent the company perspective to clinical staff.Identifies training needs and ensures staff participation during in-house training activities as required.Collaborates with Director, Clinical Operations to develop and administer an effective orientation/on-boarding process for new CTM, Lead CRA and CRA hires.Maintains awareness of overall development in the field of clinical research.Minimum Recruitment Standards:BS/BA (or equivalent) in a life sciences program or RN/BSN (or equivalent) with a minimum of 8 years direct experience in clinical studies or equivalent level of education, training and experience.Understanding of the entire clinical research process mandatory.Previous experience in personnel management within a clinical research environment preferred.At least 5 years as a Clinical Research Associate/Clinical Monitor, prefer at least 4 years as a successful Lead CRA/Clinical Trial Manager.Demonstrated ability to lead and motivate a group of clinical research personnel.IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
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