Senior Clinical Data Manager - Remote Colombia

MMS; Bogotá ciudad; Remote; COP 90,000,000 - 150,000,000; Full time

Job summary

MMS, an award-winning, data-focused clinical research organization, seeks a Data Management Lead to join remotely from Colombia. You will guide data management activities across studies, coordinate with DM suppliers and clients, and ensure smooth data flow from study setup to close-out while upholding GCP/ICH and FDA standards.

The role requires 5+ years in data management with leadership experience, deep knowledge of EDC and paper CRF systems, strong communication, and the ability to mentor

Qualifications

• 5+ years’ experience in data management field with a minimum of 1 year of experience leading projects
• Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems
• Extensive knowledge of Clinical Operations SOPs and Working Practices
• Excellent verbal and written communication skills, as well as interpersonal and organizational skills

Responsibilities

• Oversee data management from study setup to close-out and be primary contact for study-specific issues
• Coordinate with DM suppliers and clients to ensure best-fit data management solutions
• Provide mentorship and training in data management practices and SOPs
• Lead DS study documentation including CRF Completion Guidelines, Database Design, Validation specs, and DM Plans
• Support data management-related initiatives and process improvements
• Ensure adherence to GCP/ICH guidelines and FDA regulations as applicable

Education

Bachelor's or Master’s Degree in scientific or health care field

Tools

EDC systems

CRF Design Tools

Job description

MMS, an award-winning, data-focused clinical research organization, seeks a Data Management Lead to join remotely from Colombia. You will guide data management activities across studies, coordinate with DM suppliers and clients, and ensure smooth data flow from study setup to close-out while upholding GCP/ICH and FDA standards.

The role requires 5+ years in data management with leadership experience, deep knowledge of EDC and paper CRF systems, strong communication, and the ability to mentor