Senior Manager, Clinical Systems and Processes

🕒 vor 9 Tagen

🏄 California – Remote

🏄 California – Remote

💵 $137.000 - $171.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

Jetzt Bewerben

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Crinetics Pharmaceuticals

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 2015

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals ist ein Biotechnologieunternehmen, das innovative Therapien für endokrine Erkrankungen entwickelt. Das Unternehmen konzentriert sich darauf, ungedeckte medizinische Bedürfnisse zu adressieren, indem es Behandlungen für Zustände wie Akromegalie, Karzinoid-Syndrom, ACTH-abhängiges Cushing-Syndrom, kongenitale Nebennierenhyperplasie und andere endokrine Störungen schafft. Crinetics engagiert sich für die Verbesserung der Lebensqualität von Patienten durch modernste Wissenschaft und robuste klinische Studien. Ihre Pipeline umfasst vielversprechende Kandidaten wie Paltusotin, das von der US-amerikanischen Food and Drug Administration für die Behandlung von erwachsenen Patienten mit Akromegalie akzeptiert wurde. Das Unternehmen arbeitet mit Leistungserbringern im Gesundheitswesen und Stakeholdern zusammen, um sicherzustellen, dass ihre Therapien reale Probleme effektiv angehen und für Investoren Wert schaffen, indem sie Marktnischen mit signifikanten Bedürfnissen betreten.

Beschreibung

• 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

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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