Job Description
<b>Job Description Summary</b>Multiple ListingsThe SSU CRA is a site relationship management role to ensure sustainable trial start-up at Site. The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs. Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).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 25% 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 SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager</li><li>Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments</li><li>Conducts site selection visits, verifies site eligibility for a specific study</li><li>Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation</li><li>Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc.</li><li>Supports SSO Study Start-Up Manager and assigned sites in vendor set-up activities </li><li>Negotiates investigator payments as needed</li><li>Supports preparation of financial contracts between Novartis and investigational sites and investigators as needed</li><li>Updates all systems until site Green Light on an ongoing basis</li><li>Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness</li><li>Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements</li></ul><b><span>Role Requirements: </span></b><ul><li>BS/BA Degree. Degree in scientific or healthcare discipline preferred</li><li>Minimum 3 years' experience in clinical operations in a monitoring / site management role</li><li>Advanced understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring</li><li>Central/in-house monitoring or field monitoring experience is desirable</li><li>Strong site management capabilities with demonstrated negotiating and problem-solving skills</li><li>Strong interpersonal, negotiation and conflict resolution skills</li><li>Ability to manage multiple priorities and manage time efficiently</li><li>Good communication skills, ability to influence others & Relationship management, trust and rapport building</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>necessitate</span><span> adjustments to pay ranges during this period. </span><span>Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities.</span><span> The total compensation package for this position may also include other elements, including a sign-on bonus,