Clinical Operations Manager (Start-Up)
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Job Location:
Monthly Salary:
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
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 :
- Bachelors 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Six Sigma
- Lean
- Management Experience
- Process Improvement
- Microsoft Outlook
- Analysis Skills
- Warehouse Management System
- Operations Management
- Kaizen
- Leadership Experience
- Supervising Experience
- Retail Management
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
