Lead Clinical Data Management Specialist

MMS Holdings Inc; Baltimore (MD); Remote; USD 110,000 - 160,000; Full time

Job summary

MMS Holdings Inc is a data-focused clinical research organization seeking an experienced Data Manager to lead data management activities across studies. The role requires overseeing data capture, validation, and database design, while maintaining strong client relationships and regulatory compliance.

You will mentor junior staff, coordinate with suppliers and clients, and ensure project milestones are met within GCP/ICH and FDA guidelines.

Qualifications

• Bachelor’s or Master’s degree in a scientific/healthcare field or equivalent experience.
• Minimum 5+ years in data management with at least 1 year leading projects.
• Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems.
• Strong understanding of Clinical Operations SOPs and working practices.
• Excellent verbal and written communication, interpersonal and organizational skills.

Responsibilities

• Provide end-to-end data management, from study setup to close-out, as primary DM contact.
• Lead data management projects with minimal supervision and strong client interaction.
• Oversee data management documentation including CRFs, DB design, validation specs.
• Coordinate with DM suppliers and clients to ensure timely project delivery.
• Ensure adherence to GCP/ICH guidelines and FDA regulations in data handling.
• Develop training materials and mentor junior clinical data managers.

Skills

Data management

Client communication

Project leadership

Regulatory knowledge

GCP/ICH/FDA familiarity

Education

Bachelor’s or Master’s Degree in scientific/healthcare

Tools

EDC systems

CRF systems

Data management tools

Job description

MMS Holdings Inc is a data-focused clinical research organization seeking an experienced Data Manager to lead data management activities across studies. The role requires overseeing data capture, validation, and database design, while maintaining strong client relationships and regulatory compliance.

You will mentor junior staff, coordinate with suppliers and clients, and ensure project milestones are met within GCP/ICH and FDA guidelines.