Clinical Systems Coordinator

Clinical Systems Coordinator

Requirements

• Bachelor’s degree in a medical, scientific, engineering, or computer systems discipline or a commensurate combination of training and experience;
• Prior experience with industry-sponsored clinical research is strongly preferred.
• 1-2 years of prior experience working with Veeva Clinical Suite is preferred.
• A strong working knowledge of Good Clinical Practices governing human subject testing is strongly preferred.
• Strong critical thinking and discretionary decision-making skills;
• Strong organizational and time-management skills;
• Ability to multi-task and prioritize autonomously in a fast-paced environment;
• Excellent written & oral communication skills;
• Ability and willingness to travel (up to 10% of the time).

Responsibilities

• Configuring, managing, and maintaining Axogen’s Veeva Vault (eTMF, CTMS, Payments, etc.) to meet organizational and regulatory standards.
• Administering user roles, permissions, and access controls for Veeva Vault and related clinical systems to ensure system security and data integrity.
• Collaborating with IT, vendors, and external partners to address technical issues, system upgrades, validation activities, and system enhancements in compliance with Axogen’s Quality Management System.
• Managing metadata for document uploads and coordinating necessary changes with internal teams.
• Monitoring system performance, facilitating integration between clinical systems, and providing troubleshooting and resolution support.
• Assist in initiatives to validate and implement new clinical systems or upgrades, ensuring alignment with GxP standards and organizational objectives.
• Creating and maintaining system configuration guides, workflows, and user manuals to support internal teams and stakeholders.
• Ensuring backups, disaster recovery processes, business continuity plans, and audit trails are in place to maintain compliance and data security.
• Establishing and maintaining system metrics dashboards to monitor user activity, system health, and performance while preparing reports for leadership.
• Conducting Quality Control (QC) reviews of essential study documents and Trial Master Files to ensure compliance with GCP, ICH guidelines, and regulatory requirements.
• Assessing and reviewing documents with stakeholders to ensure they are inspection-ready and addressing identified gaps proactively.
• Tracking and reporting TMF health metrics (completeness, timeliness, and quality) to ensure continuous improvement and audit readiness.
• Completing annual eTMF reviews with the Clinical Operations team to ensure compliance with Axogen’s documentation standards.
• Developing and maintaining SOPs, work instructions, and detailed training materials, including user manuals, quick reference guides, and video tutorials.
• Delivering training programs for staff on clinical systems (e.g., CTMS, eTMF) and designing role-specific modules tailored to individual needs or onboarding requirements.
• Conducting periodic refresher training sessions to reinforce knowledge of regulatory requirements, system updates, and process improvements.
• Continuously enhancing training programs based on user feedback, system changes, and evolving regulatory requirements.
• Supporting change management initiatives by educating staff on new systems, upgrades, or process changes for seamless adoption and integration.
• Acting as a liaison between Clinical Systems and other departments to ensure efficient communication and resolution of system-related challenges.
• Facilitating cross-functional collaboration to align system strategies with organizational goals, prioritizing scalability, compliance, and operational excellence.
• Other projects and duties as required/assigned.

Preferred Qualifications

• Prior experience with industry-sponsored clinical research is strongly preferred.
• 1-2 years of prior experience working with Veeva Clinical Suite is preferred.
• A strong working knowledge of Good Clinical Practices governing human subject testing is strongly preferred.