The Department of Biomedical Informatics (DBMI) at Columbia University is looking to hire a Program Manager. The successful candidate will be responsible for the day-to-day operations for a recently awarded contract from the Food and Drug Administration. The candidate will work with Principal Investigator, Dr. George Hripcsak and his team.
In 2017, the FDA's Center for Biologics Evaluation and Research (CBER) launched the Biologics Effectiveness and Safety (BEST) initiative, an expansion of the CBER Sentinel System, to specifically address the unique characteristics of CBER-regulated biologic products (including vaccines, blood and blood products, tissues and advanced therapeutics). BEST is an active surveillance and evidence generation system that can support commitments of the Prescription Drug User Fee Act VI and 21st Century Cures Act of 2016. This contract will provide FDA with the support to serve in a convening role to 1) work collaboratively with FDA staff to plan, develop, coordinate, host and convene meetings and workshops, 2) conduct methods development activities, and 3) educate FDA staff and external stakeholders on the BEST infrastructure, capabilities and applications that serve FDA and stakeholder needs.
The currently available position is grant-funded.
Defines project objectives and strategic direction
Provides leadership and vision to project teams and serves as a key facilitator between multiple teams to achieve objectives of complex efforts.
Responsible for project planning, project financials, and staff direction and oversight for multiple projects.
Performs day-to -day management of the contract.
Provides technical guidance to the project team in performance of work and review quality of all work products.
Primary contact with client's technical representative.
Ensures that contract deliverables are met.
Serve as the day-to-day interface between all personnel on the project (Columbia, UCLA, Northeastern, and other subcontractors) and the FDA.
Responsible for task order management, coordinating governance, generating the management plan, populating the risk management registry, and publishing and posting of documents.
Other duties as assigned.
Master's Degree in related field (computer science, biomedical informatics, information science, data science, mathematics, statistics), with 5-10 years of experience or Master's of Business Administration (MBA) with 5-10 years of experience. PhD is preferred.
Demonstrated achievement in project management, organizational and follow-through skills, superior interpersonal, written and verbal communication skills, close attention to detail.
Ability to work cross-functionally as part of a team as well as an individual contributor.
Ability to think independently as well as perform tasks according to the directions of project leaders.
Experience interacting with all levels of faculty, management and staff, and ability to manage complex programs.
Experience with managing federal contracts is preferable.
Experience with event planning is desirable.
High degree of proficiency with computer software (MS Word, Excel, and PowerPoint, project management tools).
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 510538
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.