Job Description

Our small start-up client is adding a scientific minded Clinical Data Manager to join their team. In this role, you will oversee the data management aspects of clinical trials from beginning to end. Your main focus will be on ensuring data integrity, quality, and compliance with clinical trial requirements. This position requires a strong understanding of cardiovascular knowledge, proficiency in clinical data management processes, excellent project management skills, and the ability to collaborate effectively with cross-functional teams. If you have database/programming experience, you will have the opportunity to do both. They have a consultant who designed feasibility, and this person will manage the pivotal trial.

Your role with the company:

• Maintain and update data management documentation (e.g., data management plans, data reports, etc.).
• Perform data review and query management to ensure completeness, accuracy, and consistency of clinical trial data.
• Create recruitment statistics for clinical field staff to review with the study sites to ensure efficient recruitment.
• Regularly review protocol deviation reports to ensure trial compliance.
• Regularly review adverse events summary with clinical project manager and safety manager.
• Manage clinical trial database (Catchtrial), including data entry, cleaning, and lock activities.
• Coordinate with study teams, clinical sites, and other stakeholders to resolve data issues and ensure timely database lock.
• Ensure compliance with relevant regulatory requirements and industry standards (e.g., FDA guidelines, ICH-GCP).
• Contribute to the development and implementation of standard operating procedures (SOPs) for data management activities.
• Provide training and support to internal and external stakeholders on data management processes and systems.
• Stay aware of any noteworthy data trends.

Desired Profile:

• Bachelor’s degree in life sciences, computer science, or a related field.
• Minimum of 3-5 years of experience in clinical data management within the medical device industry. Experience with structural heart ideal.
• Strong knowledge of clinical trial processes and regulations (FDA, ICH-GCP).
• Excellent organizational, communication, and problem-solving skills.
• Ability to work effectively in a team environment and manage multiple priorities.
• Experience with EDC systems and electronic submission standards is preferred.
• Ability to interpret complex data and present it in a clear and understandable manner.

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