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 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