Senior Manager, Clinical Systems

Role Overview

• 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.

Requirements

• 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.

Tech Stack

• Google Cloud Platform
• SDLC
• Vault

Benefits

• 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