Senior Clinical Data Manager — Lead Data Projects

MMS Holdings Inc; Miami (FL); Remote; USD 95,000 - 135,000; Full time

Job summary

MMS Holdings Inc is seeking an experienced Data Manager to oversee the full data management lifecycle for clinical studies. The role requires leading projects, coordinating with clients and suppliers, and ensuring compliance with GCP/ICH and FDA guidelines. You will mentor junior staff and drive DM process improvements.

The position emphasizes independent problem-solving, high internal/external communication, and strong DM documentation skills within a collaborative team environment.

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.
• Extensive knowledge of Clinical Operations SOPs and Working Practices.
• Excellent verbal and written communication and interpersonal skills.

Responsibilities

• Provide excellent internal and external customer service across projects.
• Advise customers on best-fit EDC solutions using system proficiency.
• Interact with DM suppliers and clients to coordinate all project aspects.
• Lead data management from study set-up to close-out; main DM contact.
• Participate in protocol reviews and suggest DB capture capabilities.
• Ensure compliance with GCP/ICH guidelines and FDA regulations as applicable.
• Create training materials and mentor new data managers.
• Oversee data management activities: CRF tracking, data entry, QA, and coding.
• Develop study documentation: CRFs, guidelines, validation specs, and DMP.
• Prepare study tracking/metrics reports for the study team.
• Lead UAT for study-specific systems and applications.
• Collaborate with cross-functional teams to meet timelines.

Skills

Customer service excellence

EDC systems proficiency

Vendor/supplier negotiation

Client coordination

Data management expertise

Protocol review contribution

GCP/ICH/FDA knowledge

Mentoring/training

CRF tracking & QA

Cross-functional teamwork

SOP updates & DM process improvements

Education

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

Tools

EDC systems

Clinical database tools

Job description

MMS Holdings Inc is seeking an experienced Data Manager to oversee the full data management lifecycle for clinical studies. The role requires leading projects, coordinating with clients and suppliers, and ensuring compliance with GCP/ICH and FDA guidelines. You will mentor junior staff and drive DM process improvements.

The position emphasizes independent problem-solving, high internal/external communication, and strong DM documentation skills within a collaborative team environment.