Epidemiology Study Operations Manager

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🔥 1 minute ago

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Logo of AbbVie

AbbVie

10,000+ employees

Founded 2013

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• 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 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

🎯 Requirements

• 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)

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical/dental/vision insurance • 401(k) to eligible employees • Participation in long-term incentive programs

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