Manager, Clinical Systems

Summary

Join Apogee Therapeutics as their Manager of Clinical Systems, overseeing the planning and execution of end-to-end clinical system processes. You will provide technical and business administration support for system compliance and inspection readiness. This role requires cross-functional collaboration to drive change management and continuous improvement. Responsibilities include providing clinical system guidance, fulfilling administrative roles within Veeva Vault Clinical, building relationships with partners and vendors, and ensuring compliance with regulations. You will also generate reports, identify performance issues, and lead process development. The position involves overseeing system management, supporting archiving, collaborating with IT and QA teams, and providing user training.

Requirements

• Bachelor's Degree or higher or equivalent experience
• At least 5-8 years of experience successfully managing clinical system activities for clinical research/ biotech/pharmaceutical
• Experience with implementation and integration of clinical systems and writing and revising SOPs related to clinical systems
• Experience with computer system validation/assurance process
• Experience in managing teams in the successful execution of projects, knowledge of the principles and practices of traditional records management as applied to the pharmaceutical/ biotech or contract research organization industry
• Comprehensive knowledge of TMF Reference Model, regulations, Good Clinical Practices (GCP), and ICH Guidelines
• Strong software and computer skills, including Microsoft Office applications (Outlook, Word, Excel & PowerPoint)
• 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 team members, and functional leadership
• 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 to function as a team player
• Able to navigate complex problems, develop advanced concepts, make decisions, anticipate challenges, and propose solutions/recommendations

Responsibilities

• Provide clinical system guidance as a Subject Matter Expert (SME) for clinical system operations and requirements across study team functions, CROs, and vendors
• Fulfill administrative role within Veeva Vault Clinical, (i.e., Business Administrator and/or System Administrator.), serve as a clinical systems escalation point for stakeholders, drive resolution of issues, as appropriate
• 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
• Ensure compliance with clinical system SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available), 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
• Oversee end-to-end clinical system management to ensure adherence to processes, to meet the goals and objectives of the department, and maintain inspection readiness for all studies
• Support archiving activities to ensure adherence to processes and industry best practices
• Collaborate on projects with Information Technology (IT), Quality Assurance and Clinical System Validation teams to ensure effective implementation and integration of clinical systems, implement system releases, updates, bug fixes and/ or enhancements
• Create and provide clinical system training, Act as a primary support role for clinical system users and stakeholders
• Executes change management activities to ensure consistent application of revised standards, processes, and systems functionality including validation

Preferred Qualifications

Veeva Vault platform experience in the eTMF, CTMS and LMS vaults preferred

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• 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
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• 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