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Global drug and device development services

Feasibility Informatics Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeUnited States

About the Job

Requirements

  • A Master's degree is required.
  • Six to nine years of experience in a clinical research environment is required.
  • The employee must have the legal right to work in the country where the role is based.

Responsibilities

  • Serve as a technical feasibility strategy expert, leading and managing clinical project feasibility in support of proposal teams, assisting Business Development with cost proposals, advising on operational strategy, and supporting client interactions and long-term strategic partnerships.
  • Provide strategic feasibility expertise to internal teams and external clients, including serving as a resource for feasibility strategy and informatics services, including rescue situations.
  • Support preparation for bid defense or potential preferred partner meetings and attend or present at those meetings.
  • Hand over relevant feasibility strategy proposed during the request for proposal process to the awarded site identification team, then perform End of Site ID analysis.
  • Manage awarded standalone feasibility projects and be accountable for their delivery, including recommendations for next steps and assessment of project risks and mitigation strategies.
  • Adhere to ICON's values of collaboration, integrity, inclusion, and agility.
  • Participate in process improvement and share feasibility learning across therapeutic teams, including leveraging resources and tools, developing slides, and conducting user acceptance testing for tools.
  • Travel approximately 20% domestically and/or internationally as needed.
  • Maintain communication and relationships among relevant internal and external parties to ensure available intelligence supports data-driven feasibility strategy solutions.
  • Collect feasibility data from data assets, country associates, site-level investigators, and key opinion leader interviews when required.
  • Determine site profiles and develop appropriate feasibility strategies, including approaches and management for standalone feasibility projects.
  • Provide proposal documentation that may include incidence and prevalence, treatment practices, reimbursement practices, competitive landscape, and enrollment trend analysis.
  • Collaborate with Patient Recruitment, Start-up, and other teams as needed.
  • Evaluate feasibility data for project delivery risks, escalate identified risks, and plan or discuss solutions within the feasibility strategy, including alternative scenarios.
  • Transition all pre-award data, including strategy, to the Site Identification Manager or Lead, involving the awarded project team upon award.
  • Prepare internal project information for ad hoc information requests, including early engagement, pre-award, and post-award requests.
  • Establish proposed project viability by analyzing internal and external performance metrics and resources, including previous feasibility data, industry intelligence, electronic medical records/electronic health records, and real-world evidence data, to establish patient population demographics and data.
  • Ensure collected data is high-quality, accurate, and fully documented in ICON feasibility business systems.
  • Analyze and interpret data accurately to support feasibility strategy solutions.
  • Support or present strategic project planning at bid defense meetings, by phone or in person.
  • Initiate, conduct, coordinate, analyze, and report contracted feasibility studies on time and within budget, while managing staff resources.
  • Meet Sponsor objectives and expectations.
  • Coordinate with the Site Identification Lead according to the responsibility assignment matrix.
  • Develop country and site selection strategies; analyze and interpret results to provide protocol feedback and make country and site recommendations based on objective analysis, such as ranking.
  • Document and track feasibility study results.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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