At AbbVie, we discover and deliver innovative medicines and solutions that address complex health challenges and improve people’s lives. We are committed to making a meaningful difference for patients and communities worldwide.
As a Country Study Start-Up Specialist, you will lead country- and site-level start-up and maintenance activities for assigned clinical trials. Working with cross-functional teams, you will support timely, high-quality site activation while ensuring compliance with applicable regulations, guidelines, and AbbVie policies.
Key Responsibilities
- Lead start-up and maintenance activities for assigned studies and sites, ensuring timely delivery, quality, and compliance with approved plans.
- Develop country and site activation plans, prioritize activities, and support risk assessment and mitigation with Clinical Operations, Study Start-Up, Contract Management, Clinical Trial Supplies, Regulatory Affairs, and other relevant teams.
- Identify and communicate issues that may affect delivery and recommend solutions.
- Participate in study start-up meetings and provide updates on assigned studies and sites.
- Collect, review, and maintain essential documents in accordance with applicable standards, including ALCOA principles.
- Prepare and submit ethics committee and other local document packages, including informed consent forms, patient materials, and safety documentation.
- Coordinate country submissions, approvals, clinical supplies, and other site activation requirements.
- Collaborate with Contract Managers, Site Monitors, and Clinical Study Management Leads to support timely site activation.
- Review comments on informed consent forms and coordinate required updates and approvals.
- Initiate clinical supply shipments and complete investigational product release activities.
- Issue site green-light letters and activate sites in applicable systems.
- Maintain accurate records in Vault SSU and update country and site intelligence databases and essential document lists.
- Track study and site performance metrics and provide regular updates to relevant stakeholders.
- Support audit and inspection readiness and ensure compliance with AbbVie policies, ICH Good Clinical Practice, and applicable local requirements.
- Contribute to process improvements and support the training and mentoring of new team members.