The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries. Note: Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU Leads

• Drive and execute all start-up and maintenance activities for assigned studies and sites within the country (or countries). • Ensure on-time, on-budget, quality delivery of start-up and maintenance activities, particularly for single-country studies. • Act as a site start-up expert; support, train, and mentor Specialists, Country Start Up in new technologies and processes. • Establish country/site activation plans, risk assessment and mitigation in collaboration with cross-functional leads. • Proactively identify, communicate, and address issues impacting study delivery. • Attend regional/area start-up calls and provide study/site input. • Collect and quality check essential documents from sites (using ALCOA standards). • Prepare and submit ethics and local required submissions, customize ICFs and patient/safety materials. • Coordinate with Regulatory and CTS for CA submission and approval alignment. • Collaborate with contract manager, CRA, and other leads for timely site activation. • Review and process comments on ICFs from sites/IRB/ECs; obtain necessary approvals. • Trigger clinical supply shipments and complete IP release processes. • Issue green light letters and activate sites in IXRS. • Track all start-up and maintenance activities in Vault SSU; maintain site intelligence and EDLs. • Maintain performance metrics and KPIs; update stakeholders on progress. • Ensure audit/inspection readiness and compliance with corporate policies and global regulations. • Lead process improvement initiatives to enhance site start-up efficiency. • Function as a subject matter expert and trainer for Specialists, Country Start Up.

• Bachelor’s degree (health care/scientific discipline preferred) or equivalent experience. • At least 6 years of clinical research experience; ideally 2+ years in study start-up management for the relevant region • With regulatory submission experience will be highly preferred • TA area in oncology or immunology experience is preferred • Hands-on experience with regional clinical research regulations and processes. • Experience with central/local IRB/EC sites, particularly ICF review/approval processes. • Competency with Vault SSU for document processing, IP release, ICF review. • Experience working with remote or virtual teams. • Strong analytical, critical thinking, and decision-making skills. • Excellent interpersonal communication skills; ability to adapt to changing requirements. • Proven track record of managing multiple priorities in a fast-paced environment. • Demonstrated initiative and leadership in projects supporting the business. • Working knowledge of ICH/GCP guidelines and the country's regulatory landscape.

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