Company Description
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.
Job Description
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.Additional Information
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 regionWith 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html