Project Manager, Study I
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Job Description
Study Project Manager leading cross-functional clinical research studies at AbbVie, an innovative medicines company. Driving compliant, on-time, within-budget study planning and execution.
Responsibilities:
- Define and drive operational strategies and deliverables for one or more clinical studies
- Execute clinical studies in compliance with quality standards, ICH/GCP, global regulations, and company policies
- Manage study budgets, timelines, issues, risks, and opportunities
- Lead one or more cross-functional Clinical Study Teams
- Lead clinical operations planning through execution in a cross-functional matrix environment
- Manage vendors and external stakeholders, including site staff, Key Opinion Leaders, and patient groups
- Coach, support, delegate to, and empower cross-functional team members
- Contribute to operational efficiencies and innovative ideas
- Develop clinical study designs and associated systems, tools, and documents
- Create and oversee study budgets
- Select, scope, manage, and oversee external vendors
- Make operational decisions regarding study execution
- Create an inclusive and innovative environment for staff and studies/programs
- Provide leadership to Study Management Associates and support activities to deliver study milestones
Requirements:
- 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
- Preferred exposure to Medical Device Trial Experience
- Experience with clinical study operations management
- Knowledge of ICH/GCP, Global Regulations, and company policies and procedures
- Vendor and external stakeholder management experience
- Excellent communication and problem-solving skills
- Ability to lead cross-functional teams in a matrix environment
Benefits:
- Paid time off, including vacation, holidays, and sick leave
- Medical, dental, and vision insurance
- 401(k)
- Eligibility to participate in long-term incentive programs
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