Lead Clinical Data Management Specialist

MMS Holdings Inc; Boston (MA); Remote; USD 120,000 - 160,000; Full time

Job summary

MMS Holdings Inc. is seeking an experienced Data Manager to lead data management projects in a global CRO setting. You will oversee the full DM lifecycle from study setup to close-out, collaborating with cross-functional teams to ensure quality and regulatory compliance.

The role emphasizes mentoring junior staff, optimizing data capture in EDC and paper CRF systems, and maintaining strong client relationships while adhering to GCP/ICH guidelines and FDA regulations.

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 with at least 1 year leading projects.
• Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems.
• Excellent verbal and written communication, interpersonal and organizational skills.

Responsibilities

• Oversee data management from study setup to close-out; primary DM contact.
• Lead data management projects with limited supervision.
• Interact with DM suppliers and clients to coordinate projects and maintain relationships.
• Ensure compliance with GCP/ICH guidelines and FDA regulations.
• Develop DM documentation including CRFs, guidelines, validation specs, and DM plan.

Skills

Data management

Project leadership

Client communication

EDC knowledge

Education

Bachelor’s or Master’s degree in scientific/healthcare field

Tools

EDC systems

CRF design/tools

Job description

MMS Holdings Inc. is seeking an experienced Data Manager to lead data management projects in a global CRO setting. You will oversee the full DM lifecycle from study setup to close-out, collaborating with cross-functional teams to ensure quality and regulatory compliance.

The role emphasizes mentoring junior staff, optimizing data capture in EDC and paper CRF systems, and maintaining strong client relationships while adhering to GCP/ICH guidelines and FDA regulations.