The Clinical Systems Specialist plays a critical role in the implementation, management and optimization of clinical trial systems, ensuring their functionality and alignment with study needs. They collaborate with the System Administrator & vendor on system configuration to deliver features, fixes, and updates in alignment with the system’s roadmap, ensuring efficient operation and compliance throughout the clinical trial lifecycle. Additionally, they assist with system maintenance activities and act as the primary point of contact for training, end-user technical support, and communications, to ensure operational efficiency and compliance with internal & external requirements.

QUALIFICATIONS

• 4 - 6 years of related experience
• (Honors) Bachelor’s degree

ADDITIONAL KNOWLEDGE / SKILLS

• Education in IT, software or a related field is preferred but not required
• Strong problem-solving and analytical skills
• Excellent communication and stakeholder management skills
• Ability to work independently and as part of a team.
• A minimum of 4 years of experience in clinical systems management, technical support, or a related role within the pharmaceutical, biotechnology, or contract research organization (CRO) industry is preferred.
• Experience working with clinical trial platforms such as clinical trial management systems (CTMS), electronic data capture (EDC) systems, electronic trial master file (eTMF) systems, or other platforms is essential.
• Previous experience in system configuration, validation, and troubleshooting in a regulated environment is highly desirable.
• Understanding of clinical trial processes, regulatory requirements, including GxP, 21 CFR Part 11, and other relevant guidelines.
• Knowledge of system validation procedures, including user acceptance testing (UAT), configuration management, and compliance documentation, is essential.
• Familiarity with clinical data integrity standards and audit processes is also required.
• Strong analytical and problem-solving skills with the ability to identify and resolve complex system issues independently.
• Excellent communication skills, both verbal and written, to effectively interact with technical and non-technical stakeholders.
• The ability to prioritize tasks, manage multiple projects, and meet deadlines in a fast-paced environment.
• Attention to detail and a commitment to ensuring the accuracy and integrity of clinical data.
• Ability to work independently with minimal supervision while collaborating with cross-functional teams.
• Proactive approach to continuous learning and adapting to new technologies and industry trends
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Please refer the Job description for details