Clinical Operations Manager (Start-Up)

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

We are looking for a Clinical Operations Manager (Start-Up) to join our Clinical Site Management team, reporting directly to the Country Clinical Operations Head.

Scope

The Clinical Operations Manager (COM, Start-Up) leads the start-up and maintenance of clinical studies in the country, ensuring timely, high-quality site activation and study delivery.

They will manage and develop the CSSUS team, act as the primary point of accountability for site activities, and foster strong relationships with research sites and stakeholders. The COM drives continuous improvement and positions AbbVie as the preferred partner in clinical research.

Key Responsibilities:

• Lead, resource, hire, and develop the CSSUS team.
• Oversee and implement site activation and maintenance plans, including risk management.
• Ensure execution and quality of all SSU/site activities, adhering to regulations and budgets.
• Monitor and report site/country intelligence and study start-up metrics.
• Maintain compliance with global/local guidelines and ensure audit readiness.
• Foster collaboration and effective communication internally and externally.
• Identify staff training needs and support onboarding and process enhancements.
• Proactively manage risks, drive quality management, and contribute to process improvement.
• Oversee study budgets and resources and ensure strategic alignment with business goals

• Bachelor’s degree in Health Care/Scientific field
• Over 5 years of clinical research experience, with specific experience in managing study start up
• Preferred previous line management experience
• Led cross-functional, global and virtual teams; demonstrated stakeholder influence and alignment; modeled AbbVie leadership principles
• Ability to work autonomously; minimal oversight required
• Strong analytical and critical thinking; expert at evaluating complex issues and driving sound decisions
• Trusted communicator with persuasive, clear, and adaptable interpersonal style
• Successfully executed programs (including start-ups), managed multiple priorities in fast-paced settings
• Actively contributed to business initiatives and special projects
• Advanced knowledge of ICH and GCP guidelines and deep understanding of global clinical regulatory requirements
• Fluent in Italian and English

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