Company Description

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.

Job Description

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

Qualifications

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

Additional Information

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

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If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.

If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.

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Where We Work

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.