Our client, a leading pharmaceutical company, is hiring an eCOA Implementation Specialist on a contract basis.
Lawrence Township, NJ
• Fulfill PROA team responsibilities related to eCOA design and implementation.
• Responsible for providing input to eCOA supplier contracting, serving as client lead representative during kick-off and design meetings, providing input to the development of client eCOA standards, monitoring and adhering to vendor timelines, executing COA Management eCOA submissions, and training stakeholders.
• Coordinate with functional counterparts in the development and review of eCOA documentation, including data model specifications, project plans, user acceptance testing (UAT) scripts, device screenshots, site user guides and training slides, and data migration plans.
• Manage communications with functional stakeholders to ensure full alignment and understanding.
• Candidates must have a baccalaureate degree (advanced degree preferred) in computer science, the health sciences, or a relevant discipline.
• The candidate should possess 10 years of related experience, including 5 years of pharmaceutical industry or CRO experience.
• Experienced with eCOA design and assessment strategies, industry implementation standards for eCOA, client assessment standards, eCOA technologies, common problems in eCOA vendor management, and impacts of design decisions on timelines
• Experience in system validation and knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials
• Be abreast of rapidly changing methodological and regulatory environment with regard to eCOA
• Knowledge of the drug development process
• Skilled in technical writing and technical documentation
• Excellent interpersonal and communication skills, both written and oral. Ability to understand and communicate with matrix teams to achieve the client vision of shaping the portfolio and securing and maintaining patient access
• Ability to manage multiple priorities and projects as well as balance workload and timelines. Able to work in a fast-paced and dynamic environment
• Ability to work effectively in small teams or independently
• Ability to interact with and manage internal and external networks