Colleen Roden

Experience

1. Senior Director, Clinical Sciences and Operations

   Stryker

   Aug 2023 — Present

   Management responsibility for Clinical Operations, Clinical Evidence, and Microbiology organizations across the Endoscopy division - Partner closely with Marketing, Regulatory and R&D leaders across all Endoscopy Business Units on clinical strategy and execution to support emerging technologies, market expansions, operative efficiencies, and patient outcomes in alignment with company and divisional strategies - Partner with global teams to align clinical initiatives (AsiaPac, EU, Australia, etc.) across the business - Accountable for clinical evaluation reports to support product technical files and CE marking - Manage, analyze, implement and maintain clinical quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines - Responsible for financial management of all divisional clinical budgets

Education

• Tennessee Technological University

  B.S., Microbiology

• Middle Tennessee State University (MTSU)

  M.Sc., Microbiology

Skills

• Pcr
• Ctms
• Clinical Trial Management
• Clinical Trials
• Clinical Monitoring
• Microbiology
• Glp
• Iso Standards
• Immunoassays
• Regulatory Requirements
• Iso
• Clinical Research
• Clinical Development
• Tissue Culture
• Medical Devices
• Sop Development
• Lifesciences
• Protein Purification
• Fda
• Enzyme Assays
• Immunology
• Dna Sequencing
• Dna Extraction
• Protein Chemistry
• Life Sciences
• Regulatory Submissions
• Ich-Gcp