Senior Clinical Data Manager

MMS Holdings Inc.; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

MMS Holdings Inc. is seeking a Senior Clinical Data Manager to lead the data management process from study set-up to close-out in a fully remote capacity.

You will ensure compliance with GCP/ICH guidelines and FDA regulations while mentoring new team members and coordinating with clients and data management suppliers to drive successful project outcomes.

Qualifications

• 5+ years of experience in the data management field
• Leadership experience of at least 1 year
• Strong knowledge of EDC systems, paper CRF study systems, and hybrid CDM systems
• Understanding of Clinical Operations SOPs and Working Practices
• Experience in preparing study tracking and metric reports for project teams

Responsibilities

• Oversee all aspects of data management, including study-specific issues, data validation, and database lock processes
• Interact with clients and data management suppliers to coordinate project facets and negotiate solutions
• Develop and maintain data management documentation and participate in protocol reviews to ensure successful data capture

Skills

Data management

Leadership

Client interaction

Mentoring

Education

Bachelor's or Master's degree in science/healthcare

Tools

EDC systems

Paper CRF systems

Hybrid CDM systems

Job description

Leading data management projects in a fully remote capacity, the full-time Senior Clinical Data Manager will oversee the entire data management process from study set-up to close-out, ensuring compliance with GCP/ICH guidelines and FDA regulations while mentoring new team members.

Key responsibilities

• Oversee all aspects of data management, including study-specific issues, data validation, and database lock processes


• Interact independently with clients and data management suppliers to coordinate project facets and negotiate solutions


• Develop and maintain data management documentation and participate in protocol reviews to ensure successful data capture

Required qualifications

• Bachelor's or Master's Degree in a scientific or healthcare field preferred


• 5+ years of experience in the data management field, including at least 1 year in a leadership role


• Extensive knowledge of EDC systems, paper CRF study systems, and hybrid CDM systems


• Strong understanding of Clinical Operations SOPs and Working Practices


• Experience in preparing study tracking and metric reports for project teams