Assoc Dir Global Site & Study Operations

<h2><b>Career Category</b></h2>Clinical Development<h2></h2><h2><b>Job Description</b></h2><p><u>Accountabilities</u></p><p></p><p><span><span>•</span>The Country Study and Site Operations Head is accountable to drive all country and hub &amp; spoke execution and quality measures, including study operations, site operations, and site engagement, while ensuring operational capabilities support the delivery of the geographic portfolio with high-quality data in compliance with local regulations.</span></p><p><span><span>•</span>Ensure study execution aligns with global strategies across trials and act as a key advisor for country commitments.</span></p><p><span><span>•</span>Provide leadership and line management to the Country/Hub team, offering clear guidance, fostering capability development, and driving portfolio objectives.</span></p><p><span><span>•</span>Represent the country strategically in organizational initiatives at all levels.</span></p><p><span><span>•</span>Lead the Country Management Team (CMT).</span></p><p><span>. Ensure Adequate resourcing</span></p><h2></h2><h2><u>Responsibilities</u></h2><h2></h2><h2><span><span>•</span>Accountable for all study execution in assigned geography and quality metrics including delivering study start-up, patient enrollment, retention trends, and data flow metrics in alignment with global strategies across trials, serving as key advisor for country commitments</span></h2><h2><span><span>•</span>Oversee clinical study budgets and forecasting to ensure efficient use of resources and financial accountability.</span></h2><h2><span><span>•</span>Build, lead, and develop the Country/Hub team to effectively manage resources, ensuring appropriately skilled and high-performing staff to deliver the portfolio and meet organizational deliverables.</span></h2><h2><span><span>•</span>Drive country site engagement by leading SEL AD and/or SELs, aligning with global strategy, ensuring compliance, strengthening partnerships, and securing Partner-of-Choice positioning through innovation and leadership collaboration.”</span></h2><h2><span><span>•</span>Shape and foster collaboration between local functional teams and global study teams to drive delivery of study portfolio in assigned geography</span></h2><h2><span><span>•</span>Partner with internal stakeholders to monitor study progress and drive local actions plan &amp; issue resolution, and aggregates country progress and challenges for senior management</span></h2><h2><span><span>•</span>Represent country in governance meetings, communicating cross-study progress to region / CPSO</span></h2><h2><span><span>•</span>Advocate for study placement in considerations of strengths and growth opportunities of assigned geography</span></h2><h2><span><span>•</span>Lead internal and external meetings to ensure delivery on portfolio targets</span></h2><h2><span><span>•</span>Key advisor for site selection, and identifies &amp; communicates priority sites, allocating resources as required</span></h2><h2><span><span>•</span>Point of escalation to support resolution of country-wide issues including risks which impact delivery or quality of clinical trials and/ patient safety</span></h2><h2><span><span>•</span>Lead country-level risk assessments and implement mitigation strategies to ensure patient safety, compliance, and trial continuity</span></h2><h2><span><span>•</span>Oversees vendor selection, setup, performance oversight across local roles (study delivery, monitoring) in alignment with budget considerations and serves as point-of-escalation</span></h2><h2><span><span>•</span>Promote continuous improvement and best practice sharing to enhance operational efficiency and site engagement.</span></h2><h2><span><span>•</span>Build and develop strong local leadership and study teams to deliver on portfolio goals and support long-term organizational capability</span></h2><h2><span><span>•</span>Ensures adherence to key requirements (e.g., ICH-GCP, SOP, country regulations), study inspection readiness, internal audits and CAPA processes</span></h2><h2><span><span>•</span>Work with SDRM to ensure timely and adequately resourcing for all roles </span></h2><h2></h2><h2></h2><h2></h2><h2><span><span>•</span></span></h2><h2></h2><h2></h2><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.