Study Project Manager II

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

The Study Project Manager II drives the connection between the asset and operational delivery and execution of one or more clinical research studies. Leading the delivery of clinical operational strategies to ensure studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Study Project Manager II achieves these objectives by bringing scientific acumen, strategic asset level thinking, innovation, expertise in clinical study operations management and stakeholder management to address risks and challenges.

Qualifications

Defines and drives the study level operational strategies and deliverables – linking these to asset level goals

Brings strategic, asset level thinking and innovative problem solving to study planning and execution

Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).

Effectively present and contribute to discussions on study operations at asset level strategic meetings

Leads clinical operations planning through to execution via cross functional matrix environment and influences cross functional stakeholders to drive milestone achievement

Demonstrates the skills, experience and critical thinking to lead cross functional teams with minimal supervision.

Expertise in end-to-end clinical study operations management (all phases, set up to close out)

Coaches and mentors team members, delegates and empowers to the right level, actively contributes to Development Operations community

Demonstrates leadership with high level cross functional stakeholder management and influencing skills

Lead operational efficiencies and foster a culture of innovation

On a given study responsible for (but not limited to)

the development of the clinical study design and associated systems, tools and documents

study budget creation and oversight

vendor selection, scope development, management and oversight of external vendors

Proactively identifying risks and address and/or escalate study related issues and opportunities for efficiency

Empowered decision maker on operational aspects of study execution.

Additional Information

Bachelor’s Degree or equivalent degree is required, with Scientific background.

8 years of demonstrated pharma-related and/or clinical research related experience or equivalent required.

Preferred exposure in study initiation through study completion in Phase 1-4 and/or Medical Device Trial Experience

Expertise in end-to-end clinical study operations management

Experience with vendor selection, scope development, management and oversight of external vendors

Extensive Project Manager experience

Hybrid model: Mandaotory working onsite 3 days per week in our offices in Madrid.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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