Study Project Manager II

at  AbbVie

Company Description
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.
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.
Responsibilities :
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.

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.

Qualifications

• Bachelor’s Degree or OUS equivalent degree is required, typically in nursing or scientific field; registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is acceptable.
• Must have at least 8 years of Pharma-related/clinical research-related 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).

Additional Information
AbbVie is an equal opportunity employer and 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.
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• 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