<h3>Work Schedule</h3>Standard (Mon-Fri)<h3>Environmental Conditions</h3>Office<h3><u>Job Description</u></h3><p>Join Us as a Senior Project Manager - Make an Impact at the Forefront of Innovation. Lead or support study operational strategy and planning and oversee execution of select clinical studies (global/regional and/or local country) for assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.</p><p>In close collaboration with the Clinical Operations Program Lead (COPL) and the Clinical Operations Manager (COM) (if applicable):</p><ul><li>Support or oversee the execution of select study/ies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Client SOPs), on schedule and on budget.</li><li>Oversee Strategic Partners and/or other CROs and other vendors to meet the client obligations described in ICH-GCP and client business objectives.</li></ul><p>Studies may include but are not limited to PTA (Post Trial Access), RATIO (R&amp;D Asset Transition and Integration Office), those in wind down, etc. More than one study and/or more than one program may be assigned.</p><h3>ACCOUNTABILITIES: </h3><ul><li>Accountable for planning and operational strategy and execution for assigned clinical trials<ul><li>Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents</li><li>Challenges study team to ensure operational feasibility, inclusive of patient and site burden</li><li>Supports budget development and ensures impacts are adequately addressed</li><li>Participates in country and site feasibility/selection process, with a focus on providing country insights, alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy</li><li>Develops and manages study timelines</li><li>Challenges study team to ensure timelines meet the needs of the clinical development plan</li><li>Ensures new team members and vendors are appropriately onboarded</li><li>Identifies and oversees trial risk and mitigation</li><li>Leader of the cross functional study team</li></ul></li><li>During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place</li><li>Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly</li><li>Supports/reviews study budget planning and management and accountable for external spend related to study execution. Works closely with COM (if applicable) and COPL, Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to COM and COPL; serve as escalation point for all vendors managed by Strateg