Country Study Startup Specialist

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.

• Purpose:
  • Drive and execute start-up and maintenance activities for assigned studies and sites within the assigned country or countries.
• Responsibilities:
  • Ensure successful, timely, and quality execution of start-up and maintenance activities for assigned sites/studies, focusing on central IRB/EC sites.
  • Establish country/site activation plans and priorities, including risk assessment and mitigation plans.
  • Identify and communicate issues impacting delivery and provide solutions.
  • Attend regional/area start-up calls for input on assigned sites/studies.
  • Collect essential documents from sites and conduct quality checks.
  • Compile and submit ethics and other required local submissions.
  • Coordinate with regulatory and CTS on CA submissions and approvals.
  • Collaborate for timely site activation and review comments on ICFs.
  • Trigger clinical supply shipments and complete IP release activities.
  • Issue site green light letters and activate sites in IXRS.
  • Track start-up and maintenance activities and maintain performance metrics.
  • Ensure audit/inspection readiness and compliance with policies/procedures.
  • Participate in process improvement initiatives.

Qualifications:

• Required:
  • Bachelor’s Degree in healthcare or scientific field preferred, or equivalent experience.
  • Minimum of 1-2 years of clinical research experience, with preference for 1+ years in study start-up management in the designated region.
  • Experience working with remote/virtual teams.
• Skills:
  • Strong analytical and critical thinking skills.
  • Ability to build trust and communicate effectively.
  • Successful execution and ability to manage multiple priorities.
  • Working knowledge of ICH and GCP guidelines and the regulatory environment.

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