Senior Specialist, Country Study Start Up

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Key Responsibilities:

• Drive and execute all start-up and maintenance activities for assigned studies and sites within the country (or countries).
• Ensure on-time, on-budget, quality delivery of start-up and maintenance activities, particularly for single-country studies.
• Act as a site start-up expert; support, train, and mentor Specialists, Country Start Up in new technologies and processes.
• Establish country/site activation plans, risk assessment and mitigation in collaboration with cross-functional leads.
• Proactively identify, communicate, and address issues impacting study delivery.
• Attend regional/area start-up calls and provide study/site input.
• Collect and quality check essential documents from sites (using ALCOA standards).
• Prepare and submit ethics and local required submissions, customize ICFs and patient/safety materials.
• Coordinate with Regulatory and CTS for CA submission and approval alignment.
• Collaborate with contract manager, CRA, and other leads for timely site activation.
• Review and process comments on ICFs from sites/IRB/ECs; obtain necessary approvals.
• Trigger clinical supply shipments and complete IP release processes.
• Issue green light letters and activate sites in IXRS.
• Track all start-up and maintenance activities in Vault SSU; maintain site intelligence and EDLs.
• Maintain performance metrics and KPIs; update stakeholders on progress.
• Ensure audit/inspection readiness and compliance with corporate policies and global regulations.
• Lead process improvement initiatives to enhance site start-up efficiency.
• Function as a subject matter expert and trainer for Specialists, Country Start Up.

Required Qualifications:

• Bachelor’s degree (health care/scientific discipline preferred) or equivalent experience.
• At least 6 years of clinical research experience; ideally 2+ years in study start-up management for the relevant region
• With regulatory submission experience will be highly preferred 
• TA area in oncology or immunology experience is preferred 
• Hands-on experience with regional clinical research regulations and processes.
• Experience with central/local IRB/EC sites, particularly ICF review/approval processes.
• Competency with Vault SSU for document processing, IP release, ICF review.
• Experience working with remote or virtual teams.
• Strong analytical, critical thinking, and decision-making skills.
• Excellent interpersonal communication skills; ability to adapt to changing requirements.
• Proven track record of managing multiple priorities in a fast-paced environment.
• Demonstrated initiative and leadership in projects supporting the business.
• Working knowledge of ICH/GCP guidelines and the country's regulatory landscape.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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