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.
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As a Medical Affairs Research Manager, you will bring your Medical Affairs and pharmaceutical clinical research experience to support the successful delivery of medical research projects and designated studies in the Netherlands.
You will provide a seamless link between internal Medical Teams and healthcare professionals, acting as a subject matter expert on the management of studies and medical research projects. You will be responsible for supporting compliant execution, on-time delivery, study tracking, budget oversight, invoice management, and continuous process improvement.
You will work collaboratively with affiliate Medical Teams across therapeutic areas, medical advisors, medical science liaisons, investigators, site staff, legal teams, and other internal and external stakeholders.
In this position you will
- ✓Act as the primary point of contact for designated Medical Research Projects across affiliate Medical Teams and therapeutic areas.
- ✓Provide input into the feasibility and set-up of medical research projects and multi-country observational studies.
- ✓Coordinate research proposal submissions using relevant systems, such as SPIRIT and Veeva Vault Clinical.
- ✓Lead study status tracking using systems such as TESLA and SPIRIT and provide accurate reports to Affiliate Medical Leadership.
- ✓Develop and manage study-related documentation in compliance with applicable AbbVie standard operating procedures and clinical trial legislation.
- ✓Ensure that all pre-study activities, including Ethics Committee submissions and all required documentation, are completed accurately and within the required timelines.
- ✓Collaborate with medical advisors and medical science liaisons on investigational site selection, initiation visits, site engagements, and close-out visits.
- ✓Conduct budget negotiations with investigational sites and coordinate Clinical Study Agreement negotiations with the relevant Legal teams.
- ✓Communicate project progress and provide timely, accurate status updates and decision-support information to project teams at affiliate, area, and international levels.
- ✓Identify and manage operational issues promptly and effectively.
- ✓Provide subject matter expertise on relevant legislation and regulations governing pharmaceutical industry-supported research.
- ✓Participate in preparatory activities for regulatory audits and inspections.
- ✓Monitor study deliverables for internal teams while maintaining effective communication with all stakeholders.
- ✓Ensure the timely execution of study drug shipments and contracts.
- ✓Oversee study budgets, including accurate budget tracking and invoice management.
- ✓Develop project management processes to support the effective delivery of local studies and other medical projects in the Netherlands and identify opportunities to improve processes, systems, and the overall user experience.
- ✓Bachelor’s or master’s degree in a life science or related discipline.
- ✓At least three years of experience in industry-based pharmaceutical clinical research.
- ✓Good knowledge of clinical trial legislation, regulations, and operational requirements.
- ✓Extensive project management experience.
- ✓Fluent in Dutch and English, both written and spoken.
- ✓Excellent proficiency with standard Microsoft Office and other IT tools.
- ✓Strong understanding of study management, documentation, budget tracking, and stakeholder coordination.
- ✓High standards of ethics, compliance, and professional integrity.
This is a hybrid position with office location Hoofddorp. We welcome your application!
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.
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