Study Project Manager I (Remote)

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

• 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 AbbVie 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

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

*Level of the role will be determined based on candidate experience level.

• Bachelor’s Degree in nursing, scientific, or equivalent required; Associate’s Degree, R.N., or equivalent with relevant experience is acceptable.


• Oncology clinical trial experience is preferred
   
• 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


• Must have demonstrated a high level of core and technical competencies through management of clinical trials.


• Possess good communication skills and demonstrated leadership abilities.


• Demonstration of successful coaching and mentoring in a matrix environment; direct people management preferred.


• Considered a subject matter expert and competent in the application of Standard Business Procedures (International Conference on Harmonization, Global Regulations, Ethics and Compliance).


• Experience in successful study initiation through study completion, primary data analysis and/or in multiple phases of studies (Phase 1-3, 4).
   

Role may sit remotely anywhere in the United States.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.