Senior Manager, Clinical Systems and Processes

Crinetics Pharmaceuticals

Senior Manager overseeing clinical systems and processes at Crinetics Pharmaceuticals for enhancing clinical operations efficiency. Driving design, implementation, and improvement of clinical systems across teams.

Posted 5/28/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $137,000 - $171,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud PlatformSDLCVault

About the role

Key responsibilities & impact

Execute strategy and lead implementation or system 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 such as RBQM
Oversee and mentor the Manager, Clinical Systems and Processes, providing guidance, and supporting daily clinical systems and processes activities in alignment with leadership expectations
Serve as a primary SME on behalf of Clinical Operations for Veeva Vault Clinical Suite system configurations, architecture, and backend administration, including expert-level knowledge of the Veeva Vault Clinical Suite
Support the evaluation, piloting, and adoption of Artificial Intelligence (AI) solutions to enhance Clinical Operations efficiency, data quality, and decision-making capabilities
Support the development of an RBQM platform to enable the development of dashboards, visualizations, and tools for proactive risk identification and centralized monitoring execution across clinical studies
Lead systems integration initiatives across clinical platforms, ensuring seamless data flow, interoperability, and alignment with enterprise-wide technology strategies
Develop and execute organizational change management plans to support the successful rollout and adoption of new systems, processes, and technology solutions across internal and external stakeholder groups
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 associated documentation
Support maintenance of the clinical systems product roadmap by contributing to release planning, system upgrade cycles, system health monitoring, disaster recovery testing, and identifying enhancement opportunities aligned with clinical program goals
Manage vendor relationships for clinical systems platforms, including escalation of system issues, and coordination of release planning and upgrades, in partnership with vendors and IT stakeholders
Own the design and implementation of clinical process development frameworks, ensuring scalability, compliance, and alignment with organizational goals
Partner with the Director, Clinical Systems and Processes to develop 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 needed
Author Clinical Systems Audit Trail Review Plans and perform Audit Trail Reviews on a periodic basis
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
Support the transfer of study-specific TMFs from external vendors to Crinetics

Requirements

What you’ll need

Bachelor’s Degree with a minimum of 8 years of experience working in a clinical research environment (Master’s degree with 6+ years also acceptable)
Minimum of 6+ years of direct “hands-on” Veeva Vault Clinical Suite and other Clinical systems, with demonstrated expert-level knowledge, proficiency and systems configurations experience
Demonstrated experience with Veeva Vault Clinical Suite (TMF, CTMS, Site Connect) as a primary system administrator and SME
Proficiency with Smartsheet, including workflow design, reporting, and project tracking applications
Demonstrated experience evaluating, implementing, or overseeing Artificial Intelligence (AI) or automation solutions in a clinical operations context
Demonstrated experience driving systems integrations across clinical technology platforms
Working knowledge of 21 CFR Part 11, GxP compliance, computer systems validation (CSV), and Computer Software Assurance (CSA) principles as they apply to clinical system lifecycle management
Proven experience managing clinical system vendors in a regulated environment
Proven organizational change management experience with ability to design and execute adoption strategies across diverse internal and external stakeholder groups
Demonstrated experience developing clinical processes, SOPs, and scalable operational frameworks
Advanced knowledge of ICH/GCP guidelines, CDISC TMF Reference Model (DIA), global regulatory requirements, and inspection readiness, including experience supporting regulatory inspections and audits of clinical systems
Minimum of 5 years of people management experience, including direct supervision of managers or senior individual contributors
Excellent organizational, planning, and time management skills, with the ability to prioritize multiple complex projects simultaneously
Strong written and verbal communication skills with the ability to present and influence senior leadership.

Benefits

Comp & perks

Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
Winter company shutdown
Discretionary annual target bonus
Stock options
401k match

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Veeva Vault Clinical SuiteTMFCTMSSite ConnectSmartsheetArtificial Intelligence (AI)systems integrationorganizational change managementclinical process developmentcomputer systems validation (CSV)

Soft Skills

leadershipmentoringorganizational skillsplanningtime managementcommunicationinfluencingcollaborationproblem-solvingpresentation skills