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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.

Purpose :

This position reports into the Office of the Product Safety Team (PST) within the Clinical Sciences organization's Global Strategic Operations. Within Clinical Sciences, the Global Patient Safety and Epidemiology organization 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.

The PST is a high-profile high-impact team that leads and owns safety decisions and strategy across the product lifecycle. The team partners with stakeholders across the product lifecycle to provide innovative safety-driven strategies, which will maximize product benefit-risk for patients. The Office of the PST plays a critical role in shaping and driving the priorities of the PST by providing strategic and operational leadership oversight of the PST model.

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 (Global Regulations and AbbVie policies and procedures).

Responsibilities :

• 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 :

Note : No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

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