Country Study Start Up Specialist

About the role

AbbVie is seeking a motivated and organized professional to serve as a Country Study Start Up Specialist. In this role you will proactively coordinate start‑up activities and support the successful delivery of study and site activation processes across assigned countries.

Key responsibilities

• Ensure on‑time, high‑quality execution of start‑up and maintenance activities for assigned sites and studies.
• Develop country‑specific site activation plans, conduct risk assessments and define mitigation strategies.
• Collect essential site documents, perform quality checks, and compile ethics and local regulatory submissions, including customized Informed Consent Forms.
• Collaborate with contract managers, Clinical Research Associates, Study Start‑up Leads and Site Management Leads to achieve timely site activation.
• Review and route Institutional Review Board/Ethics Committee comments, trigger clinical supply shipments, issue green‑light letters and activate sites.
• Track all start‑up and maintenance activities, maintain local intelligence databases and performance metrics, and provide regular updates.
• Ensure audit and inspection readiness and compliance with corporate, divisional and worldwide regulations.
• Participate in process‑improvement initiatives and manage own projects to accelerate study start‑up.

Required profile

• Proactive mindset with strong organizational skills.
• Ability to work collaboratively with internal stakeholders and external partners.
• Experience managing multiple projects and delivering results under tight timelines.
• Commitment to compliance with corporate policies, divisional procedures and global regulations.
• Strong communication skills for issue identification, solution proposal and stakeholder updates.

Required skills