eCOA Project Manager

medable; Denmark; On-site; DKK 850,000 - 1,400,000; Full time

Job summary

Medable is seeking an experienced Project Manager to lead end-to-end software implementation in clinical trials, spanning from kickoff to go-live and localizations. You will work with design teams to interpret trial requirements and manage scope, timelines, and budgets while ensuring regulatory compliance.

Lead cross-functional collaboration, drive change management, and deliver robust, scalable solutions with a focus on client communication and successful deployments across European studies.

Qualifications

• Minimum of 6 years of experience or equivalent combination of education and experience.
• Proven experience in managing full lifecycle software implementation projects.
• Advanced proficiency in change management and coordinating cross-functional teams.
• Extensive experience supporting in-flight projects with adaptive approaches.
• Strong knowledge of clinical trial domains and regulatory compliance.

Responsibilities

• Manage the initial deployment lifecycle of the Medable Solution from kick-off through go-live.
• Collaborate with solution design teams to understand trial-specific requirements.
• Oversee project scope, timelines and budgets, including timecards and budget adherence.
• Align System Specifications with clinical trial protocols and schedules.
• Develop adaptive project plans to incorporate evolving client needs.
• Educate clients and internal teams on software capabilities and best practices.

Skills

Project management

Cross-functional leadership

Communication skills

Change management

Strategic planning

Education

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 equivalent

Job description

Medable's mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences.

Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place.

Responsibilities

• 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.
• Manages 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.

Experience

• 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 eq