eCOA Manager, Clinical Assessment Technologies - US - Remote

What you will do

• Serve as main contact for the eCOA vendor, Sponsor, and Worldwide study team members
• Manage vendor deliverables and timelines, as they relate to study assessments
• Negotiate with eCOA vendor and sponsor regarding eCOA scope of work (SOW)
• Review and identify study trends and proactively work with eCOA vendor and study team to address study specific requirements
• Conduct risk assessments to study due to vendor deliverable delays, availability of materials, equipment, and translations and related concerns
• Responsible for reviewing and communicating with vendor regarding system change control, closeout, and database lock activities

What you will bring to the role

• Highly organized, detail- and service-oriented with excellent problem-solving skills
• Excellent project management skills, planning, managing, monitoring, scheduling, and critiquing skills
• Excellent at meeting timelines consistently and being able to effectively work under pressure
• Strong writing and verbal communication skills in order to clearly and concisely present information
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Strong ability to handle multiple tasks and many administrative details in a fast-paced and constantly changing environment

Your experience

• Bachelor's degree, in Life Science preferred
• Minimum two years of experience working in eCOA and clinical trials
• Minimum two years of experience in project management
• The individual must demonstrate a strong ability to lead, understand policies and procedures, financial and leadership principles, possesses excellent time management and project management skills and communicate effectively.
• Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials
• Knowledge of SOPs and ICH/GCP/regulatory guidelines

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