Apogee Therapeutics - Senior Manager, Clinical Systems
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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. • Optional • PMP, PgMP, or equivalent certification preferred. • Experience in high-growth biotech or startup environments. • The anticipated salary range for candidates for this role will be $150,000-$165,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
Responsibilities
• 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.
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 • E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
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