Lead Clinical Data Manager

MMS Holdings Inc; Philadelphia (Philadelphia County); Remote; USD 90,000 - 140,000; Full time

Job summary

MMS Holdings Inc seeks an experienced Data Manager to lead end-to-end data management activities for clinical studies, coordinating with DM suppliers and clients. You will guide protocol review, data capture design, and documentation while mentoring junior staff.

You will ensure adherence to GCP/ICH and FDA regulations, oversee CRF/DB design, releases, and QC processes, and work with cross-functional teams to meet study timelines and deliverables.

Qualifications

• Bachelor’s or Master’s Degree in scientific or health care field preferred with industry or relevant experience.
• 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

• Provide data management oversight from study setup to close-out; primary contact on study-specific issues.
• Interact with DM suppliers and clients to coordinate all project facets.
• Ensure compliance with GCP/ICH guidelines and FDA regulations.
• Lead protocol review and suggest data capture in database.
• Create training materials; mentor and train new data managers.
• Oversee study documentation: CRF Completion Guidelines, DB design, edit checks, and data management plans.
• Oversee UAT and data management QC activities and reports.
• Collaborate with cross-functional teams to meet timelines and study deliverables.

Skills

Customer service

EDC systems

Data management

Communication skills

Project leadership

Mentoring/training

Regulatory knowledge (GCP/ICH/FDA)

Education

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

Tools

EDC software

CRF study systems

CDM systems

Job description

MMS Holdings Inc seeks an experienced Data Manager to lead end-to-end data management activities for clinical studies, coordinating with DM suppliers and clients. You will guide protocol review, data capture design, and documentation while mentoring junior staff.

You will ensure adherence to GCP/ICH and FDA regulations, oversee CRF/DB design, releases, and QC processes, and work with cross-functional teams to meet study timelines and deliverables.