Clinical Data Manager

• Manage clinical data processes including database design, data collection, validation, and reporting.
• Support clinical trials by ensuring high-quality, compliant data management practices.
• Collaborate with cross-functional teams to deliver accurate and timely clinical data outputs.

Requirements/Must Have:

• 3 5 years of data management experience in medical device or pharmaceutical industry.
• Experience with EDC systems, preferably Medrio or similar platforms.
• Strong understanding of Good Clinical Practices and clinical trial processes.
• Ability to design clinical databases and develop edit check specifications.
• Experience with EDC validation, including test scripts and UAT documentation.
• Strong data cleaning, query management, and data review experience.
• Ability to manage multiple studies in a dynamic environment.
• Strong analytical, problem-solving, and communication skills.

Responsibilities:

• Develop project-specific data management plans covering data collection, validation, and reporting.
• Design and manage clinical databases and edit check specifications.
• Interpret protocol requirements and support efficient EDC design.
• Administer EDC systems across multiple studies.
• Support study operations and analysis teams with data management activities.
• Create and manage data listings and support data transfers for statistical review.
• Train users on EDC systems and develop training documentation.
• Perform data cleaning, query management, and data review.
• Manage post-go-live issues and system enhancements.
• Contribute to development and maintenance of data management procedures.
• Identify process improvements and proactively address data challenges.

Should Have:

• Experience with SAS software.
• Knowledge of medical devices, particularly surgical applications.
• Strong interpersonal and teamwork skills.
• Ability to work independently with minimal supervision.

Skills:

• Clinical data management and database design.
• Data validation and quality control.
• Strong documentation and communication skills.
• Analytical and problem-solving abilities.

Qualification And Education:

• Bachelor s degree in a scientific or medical field.