eCOA Project Manager

Role Description

Manage the initial deployment lifecycle of the Medable Solution spanning project kick-off through go-live and system localization.

• Collaborate with solution design teams to ensure a comprehensive understanding of trial-specific requirements.
• Manage project scope, timelines, and financial oversight, including submitting and approving timecards (as applicable) and ensuring the project remains within budget.
• Ensure the design teams align the System Specifications to the clinical trial protocols and detailed schedules of assessments within the scope of the study contract.
• Develop adaptive project plans seamlessly incorporating evolving client needs and trial requirements without disrupting project momentum.
• Implement robust change management practices by proactively identifying, evaluating, and integrating change requests.
• Educate clients and internal teams on software capabilities, customization options, and best practices for integration into clinical trial processes.
• Provide expert oversight for ongoing projects requiring system enhancements or modifications.
• Take decisive action to realign project deliverables when requirements or priorities shift.
• Ensure continuous progress and maintain project integrity.
• Facilitate the translation of client requirements into fully functional software solutions.
• Develop and execute comprehensive, detailed project plans that strategically outline timelines, critical milestones, and optimal resource allocation.
• Support successful software implementation through coordinated planning and execution.
• Build and maintain strong, collaborative relationships with clients through transparent and consistent communication serving as the primary point of contact for all project updates, issue resolution, and ongoing support.
• Proactively identify potential risks and challenges throughout the project lifecycle.
• Develop strategic mitigation strategies that anticipate potential obstacles.
• Create comprehensive guidance materials and conduct knowledge transfer sessions for the Study Conduct team.
• Collaborate extensively with cross-functional teams including developers, product managers, and clinical trial experts.
• Facilitate cohesive communication to ensure delivery of solutions that meet complex client and regulatory expectations.
• Conduct rigorous analysis of project outcomes to identify opportunities for methodological refinement and process improvement.
• Drive continuous organizational enhancement through data-driven insights and recommendations.
• Other duties as assigned.

Qualifications

• Minimum of 6 years of experience or an equivalent combination of related education and experience.
• Proven experience in managing full lifecycle software implementation projects with a track record of supporting solution design and delivery tailored to specific client requirements.
• Advanced proficiency in change management showcasing the ability to handle complex change requests and effectively coordinate cross-functional teams with updated project objectives.
• Extensive experience supporting in-flight projects requiring adaptive approaches or enhanced oversight.
• Comprehensive understanding of clinical trial domains, specifically:
  • eCOA (electronic Clinical Outcome Assessments)
  • ePRO
  • EDC
  • DCT
• Strong knowledge of clinical trial data management processes and regulatory compliance frameworks.

Skills

• Exceptional project management capabilities, including:
  • Supporting development of detailed, strategic project plans.
  • Managing multiple complex priorities simultaneously.
  • Maintaining high-quality standards under dynamic conditions.
• Outstanding interpersonal, leadership, and communication skills with demonstrated ability to communicate effectively in both oral and written formats.
• Technical aptitude with rapid learning capability and ability to effectively coordinate utilization of diverse software tools.

Education, Certifications, Licenses

• Bachelor's degree in Computer Science, Health Informatics, or related field.
• Master's degree in Computer Science, Health Informatics, or relevant domain (preferred).
• Project Management Professional (PMP), PRINCE2, or other equivalent project management certifications.

Travel Requirements

• Flexible travel schedule to meet project and client needs potentially involving domestic and international destinations.

Benefits

• Flexible Work: Remote from the start, we believe in a flexible employee experience.
• Compensation:
  • Competitive base salaries.
  • Annual performance-based bonus.
  • Stock options for employees, aligning personal achievements to Medable's success.
• Health and Wellness:
  • Health and insurance coverage.
  • Wellness program (Mental, Physical and Financial).
• Recognition: Peer-to-peer recognition program, celebrating achievements and milestones.
• Community Involvement: Volunteer time off to support causes you care about.