Senior Manager, Clinical Systems and Processes
Crinetics Pharmaceuticals
10 days ago
Remote friendly (United States)
United States
Operations
Position Summary:
Senior Manager, Clinical Systems and Processes—SME responsible for design, implementation, and continuous improvement of clinical systems and processes across Clinical Operations. Oversees Veeva Vault Clinical Suite (TMF, CTMS, Site Connect, Study Start-up), Veeva Study Training, Smartsheet, RBQM frameworks, and AI solutions; drives change management/adoption; and manages clinical system lifecycle activities in compliance with GxP and 21 CFR Part 11. Partners with the Director to develop and scale departmental capabilities.
Responsibilities:
- Lead clinical systems implementation/enhancements (Veeva Vault, Veeva Study Training, Smartsheet, RBQM).
- Oversee/mentor the Manager, Clinical Systems and Processes.
- Provide SME support for Veeva Vault configurations, architecture, and backend administration.
- Evaluate/pilot AI solutions to improve efficiency, data quality, and decision-making.
- Support RBQM platform development (dashboards, proactive risk identification, centralized monitoring).
- Lead systems integrations and ensure interoperability with enterprise strategy.
- Develop and execute change management and adoption plans (stakeholder engagement, training, communications, post-implementation support).
- Oversee change control, validation, impact assessments, UAT, configuration records, and documentation.
- Contribute to product roadmap (release planning, upgrades, health monitoring, disaster recovery testing, enhancements).
- Manage vendor relationships for regulated clinical systems.
- Own design/implementation of clinical process development frameworks.
- Develop/monitor quality metrics and audit trail review plans; support audits/inspections.
- Manage system administration, setup, and user access reviews; support TMF transfers from external vendors.
Required:
- BS + 8 years (or MS + 6+ years) in clinical research.
- 6+ years hands-on Veeva Vault Clinical Suite and clinical systems; expert configurations; primary administrator/SME for Veeva Vault (TMF, CTMS, Site Connect).
- Smartsheet proficiency.
- Experience with AI/automation in clinical operations; systems integrations.
- Working knowledge of 21 CFR Part 11, GxP, CSV, CSA; ICH/GCP and inspection readiness (including audits/inspections).
- People management: 5+ years.
- Strong change management, SOP/process development, planning, and communication skills.
Preferred:
- Veeva Vault Clinical Suite Certified Administrator.
- Change management/project management certification (e.g., Prosci/ACMP, PMP).
- RBQM leadership; AI/ML experience.
- Agile/backlog familiarity; experience with additional clinical systems (e.g., IxRS, eISF, EDC).
Benefits (as stated):
- Discretionary annual target bonus; stock options; ESPP; 401k match; medical/dental/vision/basic life; 20 days PTO; 10 paid holidays; winter company shutdown.
Salary Range (as stated):
- $137,000–$171,000.
Senior Manager, Clinical Systems and Processes—SME responsible for design, implementation, and continuous improvement of clinical systems and processes across Clinical Operations. Oversees Veeva Vault Clinical Suite (TMF, CTMS, Site Connect, Study Start-up), Veeva Study Training, Smartsheet, RBQM frameworks, and AI solutions; drives change management/adoption; and manages clinical system lifecycle activities in compliance with GxP and 21 CFR Part 11. Partners with the Director to develop and scale departmental capabilities.
Responsibilities:
- Lead clinical systems implementation/enhancements (Veeva Vault, Veeva Study Training, Smartsheet, RBQM).
- Oversee/mentor the Manager, Clinical Systems and Processes.
- Provide SME support for Veeva Vault configurations, architecture, and backend administration.
- Evaluate/pilot AI solutions to improve efficiency, data quality, and decision-making.
- Support RBQM platform development (dashboards, proactive risk identification, centralized monitoring).
- Lead systems integrations and ensure interoperability with enterprise strategy.
- Develop and execute change management and adoption plans (stakeholder engagement, training, communications, post-implementation support).
- Oversee change control, validation, impact assessments, UAT, configuration records, and documentation.
- Contribute to product roadmap (release planning, upgrades, health monitoring, disaster recovery testing, enhancements).
- Manage vendor relationships for regulated clinical systems.
- Own design/implementation of clinical process development frameworks.
- Develop/monitor quality metrics and audit trail review plans; support audits/inspections.
- Manage system administration, setup, and user access reviews; support TMF transfers from external vendors.
Required:
- BS + 8 years (or MS + 6+ years) in clinical research.
- 6+ years hands-on Veeva Vault Clinical Suite and clinical systems; expert configurations; primary administrator/SME for Veeva Vault (TMF, CTMS, Site Connect).
- Smartsheet proficiency.
- Experience with AI/automation in clinical operations; systems integrations.
- Working knowledge of 21 CFR Part 11, GxP, CSV, CSA; ICH/GCP and inspection readiness (including audits/inspections).
- People management: 5+ years.
- Strong change management, SOP/process development, planning, and communication skills.
Preferred:
- Veeva Vault Clinical Suite Certified Administrator.
- Change management/project management certification (e.g., Prosci/ACMP, PMP).
- RBQM leadership; AI/ML experience.
- Agile/backlog familiarity; experience with additional clinical systems (e.g., IxRS, eISF, EDC).
Benefits (as stated):
- Discretionary annual target bonus; stock options; ESPP; 401k match; medical/dental/vision/basic life; 20 days PTO; 10 paid holidays; winter company shutdown.
Salary Range (as stated):
- $137,000–$171,000.