Responsibilities:
- Define and drive operational strategies and deliverables for one or more clinical studies.
- Ensure clinical research studies are executed with quality and efficiency (ICH/GCP, global regulations, AbbVie policies and procedures).
- Proactively manage budget, timelines, and study issues; drive achievement of study objectives.
- Lead cross-functional Clinical Study Teams; manage clinical operations planning through execution in a matrix environment.
- Influence cross-functional stakeholders to drive milestone achievement.
- Manage vendors and external stakeholders (site staff, Key Opinion Leaders, patient groups).
- Coach and support cross-functional team members; delegate and empower; contribute to the Development Operations community.
- Contribute to operational efficiencies and bring innovative ideas.
- Demonstrate strong communication and problem-solving; put patients/customers at the center.
- On a given study (not limited to): develop clinical study design and associated systems/tools/documents; create and oversee study budgets; manage vendor selection/scope/oversight; identify and address/escalate risks and issues; make operational execution decisions.
- Create an inclusive/innovative environment; provide leadership to Study Management Associates.
Qualifications:
- Bachelorβs degree or equivalent required.
- 6 years of demonstrated pharma-related and/or clinical research experience required.
- Preferred: exposure from study initiation through completion in Phase 1β4 and/or Medical Device Trial experience.
Benefits:
- Paid time off (vacation/holidays/sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible to participate in long-term incentive programs.