Epidemiology Study Operations Manager

Epidemiology Study Operations Manager

Abbvie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas. The Office of the Product Safety Team (PST) within the Clinical Sciences organization's Global Strategic Operations works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand, and communicate the safety profile of our drugs to protect patients worldwide. As an Epidemiology Study Operations Manager within the Office of the PST, you will support and partner with the Global Epidemiology organization to achieve its mission in managing the lifecycle of studies utilizing real world evidence and to ensure compliance with quality standards.

Responsibilities include :

• 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

This role can be remote within the US.

Qualifications :

Additional Information :

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical / dental / vision insurance and 401(k) to eligible employees.

Salary : $106,500 - $202,500