Epidemiology Study Operations Manager

AbbVie; Illinois; Presencial; USD 110.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Paid time off

Descripción de la vacante

AbbVie is seeking an Epidemiology Study Operations Manager to partner with Global Epidemiology in managing non-interventional studies and ensuring quality and compliance.

You will oversee study protocol development, vendor management, budgeting, and cross-functional collaboration to drive deliverables on time and within scope, aligning with global regulations and AbbVie policies.

Formación

• Bachelor’s degree in biological/medical science or healthcare profession.
• 6+ years of experience in healthcare, research institution, or pharmaceutical industry.
• Minimum of 2 years driving project management activities in global companies.
• Experience in drug development, non-interventional study lifecycle management, risk management, and/or Pharmacovigilance preferred.
• Ability to collaborate across functions to achieve results.
• Familiarity with medical/study terminology and concepts; proficiency in Windows/Excel and CTMS.

Responsabilidades

• Strategic management and oversight of Epidemiology-led non-interventional studies with increasing autonomy.
• Support to Study Leader for vendor selection, scope, management, and CRO oversight.
• Develop study-related deliverables: project plans, timelines, accountabilities, and document quality.
• Ensure study deliverables meet regulatory and process timelines.
• Keep cross-functional teams updated on study status and milestones.
• Use systems to track and complete study deliverables and budgets.

Conocimientos

Project management

Cross-functional collaboration

Regulatory knowledge

Pharmacovigilance

Analytical thinking

Educación

Bachelor’s degree in biological/medical science or healthcare professional

Herramientas

Windows

Excel

CTMS / Clinical trial management systems

Descripción del empleo

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook,Instagram,XandYouTube.

Purpose:

This position reports into the Clinical Sciences (CS) Product Office within the Clinical Science organization’s Global Strategic Operations. The CS Product Office, Product Safety Team (PST) and Epidemiology organizations work 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 CS Product Office 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 CS Product Office, 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 the 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 escape, 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 CS Product Office
• 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)

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• 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.

• This job is eligible to participate in our long-term incentive programs.

Note: No amount of payis 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 employer remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s 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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html