Senior Manager, Clinical Systems

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Apogee Therapeutics

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51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

💰 €149.000.000 Series B im 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics ist ein biopharmazeutisches Unternehmen im klinischen Stadium, das sich auf die Entwicklung neuartiger Biologika zur Behandlung von Entzündungs- und Immunerkrankungen konzentriert. Das Unternehmen zielt auf bedeutende Märkte in den Bereichen entzündliche und immunologische Erkrankungen ab, wie z. B. atopische Dermatitis, Asthma, chronisch obstruktive Lungenerkrankung, eosinophile Ösophagitis und andere verwandte Zustände. Apogee Therapeutics strebt an, den aktuellen Behandlungsstandard zu verändern, indem es Antikörpertherapeutika vorantreibt, die auf etablierte biologische Mechanismen abzielen und das Potenzial haben, dermatologische, respiratorische und gastroenterologische Probleme zu adressieren. Das Unternehmen ist dazu verpflichtet, ein psychologisch sicheres Arbeitsumfeld zu schaffen, während es innovative Behandlungsoptionen für Menschen mit diesen Erkrankungen priorisiert.

Beschreibung

• Provide clinical system guidance as a Subject Matter Expert (SME) for clinical system operations and requirements across study team functions, CROs, and vendors. • Lead and manage clinical system programs and projects end-to-end, including scope definition, planning, timeline management, resource coordination, and execution tracking. • Manage and support clinical system (insourced and outsourced) related projects, with a focus on IRT, site portals, CTMS and eCOA, acting as a project/program manager. • Establish and maintain project governance, including risk management, issue tracking, dependency management, and executive status reporting. • Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner. • Translate business and clinical requirements into technical specifications, ensuring alignment with IT, validation, and vendor teams for successful system implementation. • Ensure compliance with clinical system SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles, applicable regulations, GCP requirements, and industry standards. • Generate and report KPIs, metrics and analytics, identifying trends across the clinical systems portfolio, areas for improvement, and implementing changes as needed. • Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required. • Lead and support development and implementation of processes, procedures, supporting tools, and related training materials that adhere to regulatory requirements and industry best practices. • Collaborate with Information Technology (IT), Quality Assurance, and Clinical System Validation teams to ensure effective system implementation, integration, and lifecycle management, including releases, updates, bug fixes, and enhancements. • Oversee system integrations and data flows across platforms (e.g., CTMS, IRT, eCOA, eTMF, LMS), ensuring data integrity and interoperability. • Create and provide clinical system training. Act as a primary support role for clinical system users and stakeholders. • Execute change management activities to ensure consistent application of revised standards, processes, and systems functionality, including validation.

🎯 Anforderungen

• Bachelor's Degree or higher or equivalent experience. • At least 10 years of experience successfully managing clinical system activities for clinical research/biotech/pharmaceutical organizations. • Experience implementing and managing eCOA, IRT, eTMF, CTMS and LMS (Veeva Vault experience preferred). • Experience with implementation and integration of clinical systems and writing/revising SOPs related to clinical systems. • Experience with computer system validation/assurance processes. • Demonstrated experience applying project management methodologies (Agile, Waterfall, or hybrid) to deliver complex, cross-functional technical initiatives. • Proven ability to define project scope, timelines, milestones, and resource plans, and manage execution with clear accountability. • Strong program management skills, including risk management, dependency tracking, issue escalation, and stakeholder communication. • Working knowledge of data management principles, including data quality, data governance, and data lifecycle management in clinical systems environments. • Ability to interpret and analyze data outputs, dashboards, and KPIs to drive operational decisions and continuous improvement. • Familiarity with AI/ML concepts and terminology (e.g., automation, predictive analytics, NLP) and their practical applications in clinical operations. • Familiarity with software development lifecycle (SDLC) processes, including requirements gathering, UAT, release management, and post-implementation support. • Proficiency with project management and tracking tools (e.g., Smartsheet, MS Project, or similar). • Experience managing teams in the successful execution of projects; knowledge of records management practices in pharma/biotech or CRO environments. • Strong software and computer skills, including Microsoft Office applications. • Knowledge of relevant licensing and industry compliance regulations. • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless. • Demonstrated effective written and verbal communication skills with internal and external stakeholders, including the ability to communicate complex technical concepts clearly. • Able to lead initiatives and communicate effectively through presentations for external and internal audiences. • Excellent organizational skills with outstanding attention to detail and follow-through. • Able to work independently and function as a team player. • Able to navigate complex problems, develop advanced concepts, anticipate challenges, and propose solutions.

🏖️ Vorteile

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve