Job DescriptionPurpose:
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 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
Qualifications- 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)
Additional InformationApplicable 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 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 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.
