Remote IT Product Manager

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Allucent

πŸ“Remote - United States

Job highlights

Summary

Join Allucent's A-team as an IT Product Manager - Clinical and support clinical systems to optimize business processes and improve compliance.

Requirements

  • Bachelor's degree in Life Sciences, Computer Science, Information Technology, or related field. Master’s degree preferred
  • Minimum of 5 years of experience as an IT Product Manager, Business Analyst, or similar role within the CRO, pharmaceutical, or biotechnology industries, with a focus on clinical systems (CTMS, EDC, eTMF)
  • Strong understanding of clinical trial processes, regulatory requirements (e.g., FDA, GCP) and industry standards
  • Experience in leading small to medium-sized system implementation or enhancement projects
  • Experience working with external vendors, including contract negotiation and performance management
  • Business Analysis certification (e.g., CBAP, CCBA) is a plus
  • Knowledge of project management methodologies (e.g., Agile, Waterfall) is also beneficial
  • Experience with Veeva Vault Clinical is a plus
  • Ability to work in a fast-paced challenging environment of a growing company
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required
  • Excellent analytical and problem-solving skills
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
  • Detail-oriented with excellent organizational skills and ability to manage multiple projects simultaneously

Responsibilities

  • Collaborate with business stakeholders to understand needs and document detailed business requirements for clinical systems
  • Lead efforts to design, configure, test, and implement new functionalities within clinical systems, ensuring alignment with regulatory standards and business goals
  • Act as a liaison between IT, business units, and third-party vendors to facilitate communication and ensure alignment of project objectives
  • Identify opportunities for optimizing business processes within clinical operations and recommend system enhancements to improve efficiency and compliance
  • Provide end-user support, troubleshooting, and training on clinical systems to ensure optimal system usage and adoption
  • Oversee data integrity, validation processes, and reporting needs to support clinical trial activities and business decision-making
  • Ensure all clinical systems adhere to regulatory requirements (e.g., FDA, GCP, ICH), and collaborate on system validation activities as required
  • Create and maintain comprehensive documentation for system configurations, processes, and user manuals
  • Work cross-functionally with clinical operations, data management, quality, and other teams to ensure smooth integration and operation of clinical systems
  • Work with testing team to develop test plans, scenarios, and scripts to ensure the quality and reliability of clinical systems
  • Review, improve and evaluate IT processes and procedures within the Quality Management System
  • Contribute to other areas of business as required

Benefits

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for remote/hybrid* working depending on location
  • Leadership and mentoring opportunities
  • Participation in our Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms

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