Job Description
<b>Job Description Summary</b>Multiple ListingsThe Study Start-Up (SSU) Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country. Leads all SSU activities of assigned projects in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team.This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10% travel#LI-Remote<br> <b>Job Description</b><b><span>Your Key Responsibilities:</span></b><ul><li>Supports country SSU strategy in close collaboration with relevant stakeholder to ensure SSU timelines and deliverables are met according to country commitments</li><li>Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects</li><li>Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required</li><li>Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable</li><li>Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness</li><li>Implements innovative and efficient processes which are in line with Novartis strategy</li><li>Supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team.</li><li>Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned</li><li>Oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations</li><li>Leads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required</li><li>Leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead</li></ul><b><span>Role Requirements: </span></b><ul><li>BS/BA Degree. Degree in scientific or healthcare discipline preferred</li><li>Minimum 5+ years' experience in clinical operations. A role that oversees (project management) and/or monitoring clinical trials experience preferred</li><li>Capable of leading in a matrix environment, without direct reports</li><li>Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring</li><li>Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues</li><li>Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards</li><li>Strong interpersonal, negotiation and conflict resolution skills</li><li>Communicates effectively in a local/global matrixed environment</li></ul><b><span>Novartis Compensation and Benefit Summary</span></b><span><b><span><span>:</span></span></b></span><span><span><span> The pay range for this position at commencement of employment is expected to be between $</span><span>114,100 and $</span><span>211,900/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may </span><span>necess