Drive start-up and maintenance activities for assigned studies and sites in designated countries, ensuring timely and quality execution, and collaborating with cross-functional teams.

Key responsibilities include:

• Establishing country/site activation plans and priorities, including risk assessment and mitigation plans.
• Proactively identifying and communicating issues impacting delivery and proposing solutions.
• Attending regional/area start-up calls and providing input for assigned sites/studies.
• Collecting essential documents from sites and completing quality checks.
• Compiling and submitting ethics and other required local submissions.
• Coordinating with regulatory and clinical supply teams to ensure alignment with site activation requirements.
• Collaborating with contract managers, CRAs, and area CSM leads to ensure timely site activation.
• Reviewing site and/or IRB/EC comments on ICFs and routing for approval.
• Triggering clinical supply shipments and completing IP release activities.
• Issuing site green light letters and activating sites in IXRS.
• Tracking start-up and maintenance related activities in Vault SSU.
• Maintaining local country and site intelligence database and EDLs in Vault.
• Maintaining SSU performance metrics and KPIs for assigned sites/studies.
• Providing start-up updates and metrics to CCOM/COM and area SSU and CSM leads.
• Ensuring audit/inspection readiness and compliance with corporate and divisional policies and procedures.
• Participating in process improvement initiatives as required.

Requirements:

• Bachelor's degree in a health care or scientific field (or equivalent years of experience).
• Minimum 1-2 years of clinical research experience, preferably 1+ years of study start-up management experience for the designated region.
• Experience working with remote/virtual teams.
• Strong analytical and critical thinking skills, with ability to evaluate complex issues.
• Strong interpersonal skills, with ability to build trust and communicate clearly, flexibly, and adaptably.
• Demonstration of successful execution, preferably in start-up, and aptitude for managing multiple priorities in a fast-paced environment.
• Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment.

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