Global Study Start-Up Specialist

AbbVie; Waver; On-site; EUR 65,000 - 90,000; Full time

Job summary

AbbVie Belgium is seeking a proactive Country Study Start Up Specialist to coordinate start-up activities and support successful delivery of study and site activation processes. This highly collaborative role requires close interaction with internal stakeholders and external partners to ensure timely delivery and quality execution.

The CSSUS drives start-up and maintenance activities for assigned studies and sites, ensuring risk assessment, regulatory submissions, and timely site activation

Qualifications

• Master’s degree in Science, Pharmacy, or a related field.
• Some experience in clinical research, project coordination, or project management is an asset.
• Proficiency in Dutch, French & English.
• Experience working with remote/virtual teams.
• Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
• Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast-paced environment.

Responsibilities

• Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies.
• Establish the country/site activation plans and priorities including risk assessment and mitigation plans.
• Proactively identify and communicate issues impacting delivery and providing proposed solutions.
• Coordinate with Regulatory Competent Authority submission and approval status to assure alignment with other site activation requirements.
• Collaborate with Contract manager, Clinical Research Associate, Study Start up Lead and Site Management Lead as required to assure timely site activation.
• Reviewing site and/or Institutional Review Board/Ethics Committee comments on ICFs and routing for approval by required functional areas.
• Trigger clinical supply shipments.
• Maintain Study Start-Up performance metrics and KPIs for assigned sites/studies.
• Provide start up updates and metrics.
• Ensure audit/inspection readiness.

Skills

Dutch

French

English

Education

Master’s degree in Science/Pharmacy or related field

Job description

AbbVie Belgium is seeking a proactive Country Study Start Up Specialist to coordinate start-up activities and support successful delivery of study and site activation processes. This highly collaborative role requires close interaction with internal stakeholders and external partners to ensure timely delivery and quality execution.

The CSSUS drives start-up and maintenance activities for assigned studies and sites, ensuring risk assessment, regulatory submissions, and timely site activation