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AI Summary

Advise clients on data handling strategy and oversee the planning, execution, and communication of data changes across clinical projects, including managing related JIRA tickets. Ensure regulatory compliance and quality, review Looker reports and visualizations, collaborate with study teams, and drive continuous improvement in data management processes.

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

  • Data Strategy: Provide expert advice to clients in development of Data Handling Guidelines (DHG)
  • Data Correction Oversight: Advise on and manage the execution of corrections via Data change requests within the Medable platform.
  • Data Change: Oversee the planning, execution, changes and communicate between internal and external stakeholders.
  • Ticketing system: Handling the JIRA ticketing system to handle the tickets to the internal team to implement the data change requests.
  • Quality Assurance: Ensure compliance with regulatory requirements and data changes by overseeing the protocol across all clinical projects.
  • Reporting and Visualization: Review comprehensive reports, dashboards, and visualizations through Looker to communicate findings effectively to internal and external stakeholders.
  • Cross-Functional Collaboration: Partner with internal and external study teams to ensure seamless data workflows and project execution.
  • Innovation and Improvement: Stay updated on industry trends, tools, and best practices, driving continuous improvement in data management processes.
  • Other duties as assigned

Experience

  • 2+ years of experience in clinical data management, or a combination of education and experience.

Skills

  • Technical Skills:Tools: Good knowledge of tools like JIRA ticketing system, Confluence, Looker etc. will add advantage
  • Leadership: Proven ability to lead teams, manage multiple projects, and meet tight deadlines.
  • Communication: Excellent verbal and written communication skills to effectively present findings and influence decision-making.
  • Experience with electronic data capture (EDC) systems is preferred.
  • Knowledge of regulatory guidelines (e.g., FDA, EMA) is preferred.

Education, Certifications, Licenses

  • Bachelor's degree in Computer Science, Health Informatics, or related field.

Travel Requirements

  • As Needed

At Medable, we believe that our team of Medaballers is our greatest asset. That is why we are committed to your personal and professional well-being. Our rewards are more than just benefits - they demonstrate our commitment to providing an inclusive, healthy and rewarding experience for all our team members.

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

Medable is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or would like to request an accommodation due to a disability, please contact us at hr@medable.com.

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