Clinical Trials Manager

Job Description The Clinical trial manager is responsible for the operational management of clinical trials studies. Primary responsibilities include the direction, planning, execution, and implementation of the various studies. This position requires routine interaction with key internal and external stakeholders, communicating clinical status, and troubleshooting routine inquiries. The position also requires experience with regulatory authorities such as the FDA and managing global and multicenter trials. Responsibilities: Lead the studies and as such, manage internal and external stakeholders. Provide Clinical Operations expertise and strategic leadership in the evaluation, selection, and management of Global Contract Research Organizations (CROs) and other external vendors to ensure successful first in Human clinical trial implementation and execution in several compounds, indications and therapeutic areas. Proactively manage CRO in all aspects of study progress from planning to close-out. Collaborate cross functionally with the program development functions to deliver trials according to plan and in the highest quality standards. Contribute to the development and presentation of clinical trial operational strategy and updates to senior/executive leadership. Oversee, manage, and ensure clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs]) Contribute to global regulatory submissions (FDA, EMA, and other governing regulatory bodies) Develop, review and approve Clinical Quality Documents Manage clinical trials budgets, providing ongoing financial reporting and projections. Facilitate the development of clinical trial agreements and other relevant documents. Contributes and/or authors the creation and finalization of key trial documentation: Protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc. Liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships. Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed. Requirements: Prior experience +5 years of active monitoring, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment. M.Sc. / Ph.D or M.D in relevant disciplines Strong knowledge of GCP and regulatory requirements Excellent written and oral English communication skills Good organizational abilities and attention to details Strong decision-making skills Ability to work flexible hours High presentation and interpersonal skills Computer literate Fluent Hebrew and English Strong communication and organizational skills Strong project management skills Experience with supply chain management Ability to flag issues in a timely manner perform issue escalation. Flexible and able to work in a changing environment Team player who can also operate independently Vendor/CRO and budget management skills Travelling may be required