Senior Manager, Clinical Systems and Processes

Crinetics Pharmaceuticals•Headquarters, KY

1d•$137,000 - $171,000•Onsite

About The Position

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Senior Manager, Clinical Systems and Processes will serve as a key subject matter expert (SME) responsible for driving the design, implementation, and continuous improvement of clinical systems and processes across Clinical Operations. This role will provide advanced oversight and expertise across Veeva Vault Clinical Suite (TMF, CTMS, Site Connect, Study Start-up), Veeva Study Training, Smartsheet, Risk-Based Quality Management (RBQM) frameworks, and emerging Artificial Intelligence (AI) solutions. The incumbent is also responsible for change management, solutions adoption, and clinical system lifecycle management. The Senior Manager provides clinical oversight for computer systems validation (CSV), Computer Software Assurance (CSA), system change control, vendor governance, and clinical technology product roadmap activities in compliance with GxP and 21 CFR Part 11 requirements. This individual will partner closely with the Director, Clinical Systems and Processes to develop and scale departmental capabilities. The incumbent will ensure that all clinical systems and processes are managed in accordance with ICH/GCP guidelines, relevant regulations, and Crinetics SOPs, while fostering a culture of innovation, quality, and operational excellence.

Requirements

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.

Nice To Haves

Veeva Vault Clinical Suite Certified Administrator or equivalent Veeva platform certification.
Formal certification or training in Change Management (e.g., Prosci, ACMP) or Project Management (e.g., PMP).
Experience leading Risk-Based Quality Management (RBQM) platform preferred.
Experience with AI/ML platforms applied to clinical data management or trial oversight.
Familiarity with Agile methodologies and product backlog management as applied to clinical technology systems.
Experience with additional clinical systems (e.g., IxRS, eISF, EDC, etc.).

Responsibilities

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. This includes stakeholder engagement, user training programs, communication strategies, and post-implementation support.
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.
Other duties as assigned.