Merav Hareli Email & Phone Number

Clinical Operations Manager. Over 16 years experience in clinical trials. Experienced leader who is able to bring a fresh perspective to operations. Has strong grasp of financial concepts, and possesses the ability to translate strategic priorities into clear plans. Demonstration of excellent communication skills, flexible thinking.Proven management ability and commitment to quality, highly motivated and dedicated to work.A high level management of global clinical team, management of multinational global Phase II/III/IV studies, medical device Pivotal study. Managing trials from start up, to project close out. My current role as Clinical Operations Manager: Direct Management of 3 Clinical Team Mangers (CTMs) and 2 IH-CRAs. Key responsibilities: Manage, support and oversee the clinical activities in Europe and Israel for Pivotal complex study to be submitted to the FDA. Engage and motivate the team. Managing 3 CROs overseeing their performance, monitoring activities, regulatory, including budget, SOW and OOS. Manage Spain, lead enrolling country in EU. Manage and oversee data cleaning activities for interim analysis and towards DBL. Meet project deliverables and milestones. Work cooperatively with company clinical team and other departments in US and Israel, listen and brainstorm to resolve issues. Interview and recruit new employees for the clinical department. Manage successfully audits and project/region CAPAs. Create and develop clinical and project plans. Create, update and review of clinical SOP’s Prepare and present at various meetings (internal and external). Prior to working in clinical trials, had nine years pharmaceutical marketing experience, including managing a medical representative team, marketing management, sales and promotion. Vast clinical knowledge and experience has been gained in: CNS, Gastroenterology, Intervention Cardiology (Stent, Cutting Balloon), infectious disease, Hematology, Pediatric, Endocrinology, and Fertility.

Listed skills include Clinical Monitoring, Clinical Managment, Clinical Trials, Cro, and 5 others.