Study Project Manager I

The Study Project Manager I drives the connection between science and operational delivery and ensures operational excellence in planning and execution of clinical research studies across all development stages. The Study Project Manager I is responsible for and ensures clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Study Project Manager I achieves these objectives by bringing scientific acumen, strategic thinking, innovation, experience in clinical study operations management and stakeholder management to address risks and challenges. The Study Project Manager I serves as leader of one or more cross functional Clinical Study Teams, leading clinical operations from planning through to execution in a cross functional matrix environment.

Responsibilities:

• -Defines and drives the operational strategies and deliverables for one or more clinical studies

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

-Proactively manages budget, timelines and study issues; brings scientific acumen, technical expertise and global mindset to drive achievement of study objectives

-Leader of the cross functional Clinical Study Team

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

-Effectively manages vendors and a diverse set of external stakeholders including site staff, Key Opinion Leaders and patient groups

-Brings a growth mindset, demonstrated by a willingness to continuously learn, grow and adapt, give and receive feedback, see challenges as opportunities

• -Coaches and effectively supports cross functional team members, delegates and empowers to the right level, actively contributes to Development Operations community

-Contributes towards operational efficiencies and brings innovative ideas to their teams and studies

-Demonstrates excellent communication and problem solving skills

-Puts patients and customers at the center of what we do

-Navigates ambiguity and thrives even when not having all the information

• 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.

• • creating an inclusive and innovative environment where staff and studies/programs will succeed

• Provide leadership to Study Management Associates – lead, delegate and support activities to deliver on study milestones

• Bachelor’s Degree or equivalent degree is required,

• 6 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

• Hybrid model: mandatory onsite work 3 days per week in Schaffhausen (Tuesday-Thursday)

Abb Vie 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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