Study Project Manager I - Hybrid
AbbVie · Cambridge, MA · 1 mo ago
Project ManagementFull-time
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
- Learns, grows and adapts, gives and receives feedback, sees challenges as opportunities
- Coaches and effectively supports cross functional team members, delegates and empowers to the right level
- Contributes towards operational efficiencies and brings innovative ideas to their teams and studies
- 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, being an empowered decision maker on operational aspects of study execution and creating an inclusive and innovative environment where staff and studies/programs will succeed
- Provides leadership to Study Management Associates – lead, delegate and support activities to deliver on study milestones
Qualifications
- 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