Epidemiology Study Operations Manager
AbbVie
- North Chicago, IL
- Permanent
- Full-time
- Strategic management and oversight of Epidemiology-led non interventional studies with progressive autonomy
- Provide support to the Study Leader for vendor selection, scope development, management, and oversight of external vendors/CROs
- Manage and coordinate the development of study-related deliverables including development of project plans/timelines, confirming accountabilities, document quality, driving completion of actions and escalating obstacles/risks
- Drive study-related deliverables to ensure regulatory and process timelines are met
- Responsible for relevant updates to the cross-functional team and stakeholders on study status
- Leverage applicable systems and processes to enable successful tracking and completion of the study and study-related deliverables
- Coordinate the development, review and approval of study protocol and other study-related documents
- Maintain study-related documents (e.g., meeting minutes, IRB/EC approvals) in the appropriate document repository
- Responsible for oversight of funds spent against approved budget
- Proactively identify, address and escalate, as appropriate, project-related issues
- Identify opportunity areas for efficiency and participate in department related projects in order to achieve operational excellence within Global Epidemiology and the Office of PST
- Build solid foundation in understanding regulations and applies knowledge or regulations to guide the development study-related deliverables
- Collaborate effectively to build and leverage relationships across functions and organizations to achieve business results
- Participate in audit and inspection preparation and execution activities
- Bachelor's degree in biological/medical science or healthcare professional
- 6+ years of experience working in healthcare, research institution, or pharmaceutical industry
- A minimum of 2 years driving project management activities or operational experience within global companies
- Preferred experience in one of the following areas: drug development, non-interventional study lifecycle management, risk management, and/or Pharmacovigilance
- Demonstrated ability to work and collaborate with others to build/leverage relationships
- Ability to adopt process and technology changes
- Familiarity with medical and study terminology and concepts is desirable
- Proficiency in computer skills (Windows, Word, Excel) and in databases (e.g., clinical trial management system)