Epidemiology Project Manager, Epidemiology & Real World Evidence

GSK•Durham, NC

7d•Hybrid

About The Position

ViiV Healthcare is recruiting for the role of Project Manager, Epidemiology & Real World Evidence (RWE) reporting to the Strategy & Governance Director, Epidemiology & Real-World Evidence. Working in a fast paced and dynamic environment, this role will directly contribute to the conduct of critical Epidemiology & RWE studies being conducted across multiple countries on utilization, safety and effectiveness of drugs used for the treatment or prevention of HIV.

Requirements

Master’s level degree in epidemiology, public health or related field of study
1+ years of relevant experience in a research organization, academic center, or pharmaceutical industry; preferably in pharmacoepidemiology, clinical epidemiology, or related area
Experience managing external vendors or contract research organizations.
Experience working with real-world data sources such as claims, electronic health records or registries.

Nice To Haves

PhD in epidemiology, public health or related discipline.
Experience in the pharmaceutical, biotechnology, medical device, or CRO sector.
Knowledge of regulatory considerations for observational studies and post-approval commitments.
Familiarity with advanced epidemiologic methods (causal inference, propensity scores, target trial emulation).
Track record of contributing to publications, regulatory documents, or scientific presentations.
Experience with budget forecasting and basic financial management for projects.
Knowledge of clinical research concepts, practices, and FDA regulations regarding drug development phases, clinical research, and data management methods
Knowledge and experience working in infectious disease area, HIV treatment and prevention
Demonstrated effective communications (written, verbal and presentation skills) in a cross-functional collaborative environment
Demonstrated ability to balance multiple and complex tasks, operate in a team environment, and be flexible in taking on and performing assignments as necessary

Responsibilities

Provide operational support for late phase/phase 4 studies conducted by the ViiV Epidemiology & RWE team including providing needed documentation for IRB/ethics committee submissions and site start up
Oversee issue management related to study conduct, operations and vendor management including ensuring on time deliverables
Work with members of Epidemiology & RWE team to develop non-interventional study protocols and conduct research studies on disease burden and drug effectiveness/safety
Ensure potential projects risks are escalated to the relevant Epi & RWE team members
Conduct comprehensive literature reviews on topics related to the research portfolio
Collaborate with analysts and statisticians to conduct analyses of in-house data sources
Contribute to the development and dissemination of study publications
Communicate project results to internal and external stakeholders and convey complex data in tangible terms for different audiences
Manage internal and external stakeholder relationships
Schedule and attend regular study team meetings with internal stakeholders and external suppliers as needed
Provide additional operational support to the ViiV Epidemiology and RWE team as needed including audit support, taking meeting minutes, developing and maintaining SharePoint sites, etc.