Clinical Systems Product Manager

2 weeks ago

Cary, North Carolina, United States Allucent Full time

We are seeking a highly skilled Clinical Systems Product Manager to join our team at Allucent.

This individual will be responsible for supporting and optimizing clinical systems, working closely with business units, IT, and external vendors to gather requirements, define business processes, and implement technology solutions that align with the organization's clinical trial management goals.

The ideal candidate will have experience in clinical systems, such as CTMS, EDC, and eTMF, as well as a strong understanding of the CRO industry and regulatory environment.

This role requires a blend of technical expertise, problem-solving skills, and a deep understanding of clinical operations to optimize systems that support clinical trials and improve business processes.

Key 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.

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.

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.

Disclaimer:

Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.

#LI-Hybrid #LI-DF1

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