Remote IT Product Manager

Summary

Join Allucent as an IT Product Manager - Clinical and support clinical systems to optimize business processes and improve compliance. As a key member of the A-team, you will collaborate with stakeholders, design and implement new functionalities, and ensure alignment with regulatory standards.

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

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