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Senior Manager, Clinical Systems

1 month, 1 week ago
United States
Full-time
Lead
Program Manager
Project and Program Management
Agile GCP
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 22

Description

  • Serve as the clinical systems subject matter expert for clinical system operations and requirements across study teams, CROs, and vendors.
  • Lead clinical system programs and projects end-to-end, including scope definition, planning, timelines, resource coordination, and execution tracking.
  • Manage projects related to IRT, site portals, CTMS, and eCOA as a project or program manager.
  • Establish and maintain governance processes, including risk management, issue tracking, dependency management, and executive status reporting.
  • Translate business and clinical requirements into technical specifications for IT, validation, and vendor teams.
  • Collaborate with IT, Quality Assurance, and Clinical System Validation teams to support system implementation, integration, and lifecycle management.
  • Oversee integrations and data flows across systems such as CTMS, IRT, eCOA, eTMF, and LMS to ensure data integrity and interoperability.
  • Ensure compliance with SOPs, GDocP, ALCOA-CCEA principles, regulations, GCP requirements, and industry standards.
  • Generate KPIs, metrics, and analytics to identify trends, improvement opportunities, and remediation needs.
  • Create training materials, provide clinical system training, and serve as a primary support resource for users and stakeholders.
  • Lead change management activities related to revised standards, processes, system functionality, and validation.

Requirements

  • Bachelor's degree or higher, or equivalent experience.
  • At least 10 years of experience managing clinical system activities in clinical research, biotech, or pharmaceutical organizations.
  • Experience implementing and managing eCOA, IRT, eTMF, CTMS, and LMS.
  • Veeva Vault experience preferred.
  • Experience with clinical system implementation, integration, and writing or revising related SOPs.
  • Experience with computer system validation or assurance processes.
  • Demonstrated use of project management methodologies such as Agile, Waterfall, or hybrid approaches.
  • Ability to define scope, timelines, milestones, and resource plans and manage execution with 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.
  • Ability to analyze data outputs, dashboards, and KPIs to support operational decisions and continuous improvement.
  • Familiarity with AI/ML concepts and terminology, such as automation, predictive analytics, and NLP.
  • Familiarity with software development lifecycle processes, including requirements gathering, UAT, release management, and post-implementation support.
  • Proficiency with project management tools such as Smartsheet or MS Project.
  • Experience managing teams and knowledge of records management practices in pharma, biotech, or CRO environments.
  • Strong Microsoft Office and general computer skills.
  • Knowledge of relevant licensing and industry compliance regulations.
  • Strong written and verbal communication skills, including the ability to explain complex technical concepts clearly.
  • Ability to lead presentations for internal and external audiences.
  • Excellent organizational skills with strong attention to detail and follow-through.
  • Ability to work independently and as part of a team.
  • Ability to solve complex problems, develop advanced concepts, anticipate challenges, and propose solutions.
  • PMP, PgMP, or equivalent certification preferred.
  • Experience in high-growth biotech or startup environments preferred.

Benefits

  • Anticipated salary range of $150,000-$165,000 per year.
  • Market-competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Opportunities for professional growth with access to development resources.
  • Regular all-team in-person meetings to build relationships and solve problems.
  • A culture grounded in C.O.R.E. values: Caring, Original, Resilient, and Egoless.

Interested in this position?

Apply directly on the company website

Apply Now

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