Senior Manager, Clinical Systems and Processes

This is a fully remote position, open to applicants in California.

📋 Description

• Implement strategies and lead the enhancement of clinical systems, including Veeva Vault Clinical Suite (TMF, CTMS, Site Connect, Study Start-up), Veeva Study Training, Smartsheet, and other Clinical Operations platforms like RBQM.

• Supervise and mentor the Manager of Clinical Systems and Processes, providing direction and support for daily operations aligned with leadership expectations.

• Act as the primary Subject Matter Expert (SME) representing Clinical Operations for the configurations, architecture, and backend administration of the Veeva Vault Clinical Suite, possessing expert-level knowledge of the system.

• Facilitate the assessment, piloting, and implementation of Artificial Intelligence (AI) solutions to improve efficiency, data quality, and decision-making in Clinical Operations.

• Assist in the creation of an RBQM platform to develop dashboards, visualizations, and tools for proactive risk identification and centralized monitoring of clinical studies.

• Lead integration initiatives across clinical platforms to ensure seamless data flow, interoperability, and alignment with enterprise-wide technology strategies.

• Develop and implement organizational change management plans to ensure the successful deployment and adoption of new systems, processes, and technology solutions among internal and external stakeholders.

• Oversee system-level change control and validation activities for clinical systems in compliance with GxP, 21 CFR Part 11, and SDLC standards, including impact assessments, user acceptance testing (UAT), configuration records, and relevant documentation.

• Contribute to the maintenance of the clinical systems product roadmap by participating in release planning, system upgrade cycles, system health monitoring, disaster recovery testing, and identifying enhancement opportunities that align with clinical program objectives.

• Manage vendor relationships for clinical systems platforms, including addressing system issues and coordinating release planning and upgrades in collaboration with vendors and IT stakeholders.

• Lead the design and execution of clinical process development frameworks, ensuring scalability, compliance, and alignment with organizational objectives.

• Collaborate with the Director of Clinical Systems and Processes to establish departmental policies, procedures, SOPs, and strategic plans.

• Oversee the development and monitoring of clinical system quality metrics and compliance reporting tools, presenting findings to senior leadership as required.

• Create Clinical Systems Audit Trail Review Plans and conduct periodic Audit Trail Reviews.

• Provide oversight and support for TMF, CTMS, and other clinical system audits and regulatory inspections.

• Manage system administration, study-related set-up, and user access reviews across clinical systems.

• Assist in transferring study-specific TMFs from external vendors to Crinetics.

⛳️ Requirements

• Bachelor’s Degree with at least 8 years of experience in a clinical research environment (Master’s degree with 6+ years is also acceptable).

• Minimum of 6+ years of direct hands-on experience with Veeva Vault Clinical Suite and other clinical systems, demonstrating expert-level knowledge and proficiency in system configurations.

• Proven experience as a primary system administrator and SME for Veeva Vault Clinical Suite (TMF, CTMS, Site Connect).

• Proficiency in Smartsheet, including workflow design, reporting, and project tracking applications.

• Demonstrated experience in evaluating, implementing, or overseeing Artificial Intelligence (AI) or automation solutions in a clinical operations setting.

• Proven ability to drive systems integrations across clinical technology platforms.

• Familiarity with 21 CFR Part 11, GxP compliance, computer systems validation (CSV), and Computer Software Assurance (CSA) principles as they relate to clinical system lifecycle management.

• Proven experience in managing clinical system vendors in a regulated environment.

• Strong organizational change management experience with the capability to design and implement adoption strategies across varied internal and external stakeholder groups.

• Demonstrated experience in developing clinical processes, SOPs, and scalable operational frameworks.

• Advanced knowledge of ICH/GCP guidelines, the CDISC TMF Reference Model (DIA), global regulatory requirements, and inspection readiness, including experience with regulatory inspections and audits of clinical systems.

• At least 5 years of experience in people management, including direct supervision of managers or senior individual contributors.

• Exceptional organizational, planning, and time management skills, with the ability to prioritize multiple complex projects simultaneously.

• Strong written and verbal communication skills, capable of presenting to and influencing senior leadership.

🏝️ Benefits

• Health insurance plans for employees (and their families) covering medical, dental, vision, and basic life insurance.

• 20 days of paid time off (PTO).

• 10 paid holidays.

• Winter company shutdown.

• Discretionary annual target bonus.

• Stock options.

• 401k match.