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Epidemiology Study Operations Manager

3 months ago

California, United States AbbVie Full time

Company Description

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. For more information about AbbVie, please visit us Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description

This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety, Epidemiology & R&D Quality Assurance ( PSEQ) organizations Global PV Strategy Management Office. The PPS 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 autonomyProvide support to the Study Leader for vendor selection, scope development, management, and oversight of external vendors/CROsManage 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/risksDrive study-related deliverables to ensure regulatory and process timelines are metResponsible for relevant updates to the cross-functional team and stakeholders on study statusLeverage applicable systems and processes to enable successful tracking and completion of the study and study-related deliverablesCoordinate the development, review and approval of study protocol and other study-related documentsMaintain study-related documents (e.g., meeting minutes, IRB/EC approvals) in the appropriate document repositoryResponsible for oversight of funds spent against approved budgetProactively identify, address and escalate, as appropriate, project-related issuesIdentify opportunity areas for efficiency and participate in department related projects in order to achieve operational excellence within Global Epidemiology and the Office of PSTBuild solid foundation in understanding regulations and applies knowledge or regulations to guide the development study-related deliverablesCollaborate effectively to build and leverage relationships across functions and organizations to achieve business resultsParticipate in audit and inspection preparation and execution activities
Qualifications
Minimum Requirements:Bachelors degree in biological/medical science or healthcare professional6+ years of experience working in healthcare, research institution, or pharmaceutical industryA minimum of 2 years driving project management activities or operational experience within global companiesPreferred Skills:Preferred experience in one of the following areas: drug development, non-interventional study lifecycle management, risk management, and/or PharmacovigilanceOther Required Skills:Demonstrated ability to work and collaborate with others to build/leverage relationshipsAbility to adopt process and technology changesFamiliarity with medical and study terminology and concepts is desirableProficiency in computer skills (Windows, Word, Excel) and in databases (e.g., clinical trial management system)
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit