Project Manager, Study

Company Description

About Abb Vie
:
Abb Vie'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 Abb Vie, please visit  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

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.

• 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

• 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 elevate 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

* This is a hybrid position onsite T‑TH. Lake County, IL office is preferred. Open to considering candidates based in Irvine, CA;
San Francisco, CA;
Florham Park, NJ

• 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

• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting…