Hybrid Study Start-Up Specialist (Remote Options)

NHSHP; New Hampshire; Hybrid; USD 90,000 - 120,000; Full time

Job summary

AbbVie is seeking a Country Study Start-Up Specialist to lead country- and site-level start-up and maintenance activities for assigned clinical trials. You will work with cross-functional teams to support timely site activation while ensuring compliance with regulations and AbbVie policies.

Join a team focused on delivering high-quality start-up deliverables, coordinating ethics submissions, and maintaining essential documents across sites in a hybrid work environment.

Qualifications

• Fluency in Dutch language required.
• Bachelor's degree or equivalent qualification; a health-related degree in medicine, science, nursing, or pharmacy is preferred.

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.

Skills

Dutch language

Education

Bachelor's degree or equivalent

Job description

AbbVie is seeking a Country Study Start-Up Specialist to lead country- and site-level start-up and maintenance activities for assigned clinical trials. You will work with cross-functional teams to support timely site activation while ensuring compliance with regulations and AbbVie policies.

Join a team focused on delivering high-quality start-up deliverables, coordinating ethics submissions, and maintaining essential documents across sites in a hybrid work environment.