Senior Clinical Data Manager - Lead Data Projects & EDC

MMS Holdings Inc; Bridgeport (CT); Remote; USD 90,000 - 130,000; Full time

Job summary

MMS Holdings Inc in Bridgeport, CT is seeking an experienced Data Management Lead to drive study data integrity, regulatory compliance, and project success. This role requires strong leadership, deep knowledge of EDC systems, and the ability to guide data management activities across the lifecycle.

You will oversee end-to-end data management, mentor junior staff, and partner with clients and vendors to ensure timely delivery of clean datasets for regulatory submissions.

Qualifications

• Bachelor’s or Master’s degree in scientific or healthcare field preferred with industry 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, interpersonal and organizational skills.

Responsibilities

• Oversee data management from study setup to study close-out as primary DM contact; possess high-level drug development knowledge related to data management.
• Actively participate in protocol reviews with clients and suggest how to capture protocol information in databases.
• Provide oversight and resolve all data management processing issues including CRF tracking, data entry, external data integration, data validation, queries, AE coding, SAE reconciliation, database lock, and QC audits.
• Develop data management study documentation such as CRFs, Completion Guidelines, Database Design via annotated CRFs, validation specs, and DM Plan.
• Prepare study tracking and metric reports for the study team and oversee UAT of study-specific systems; coordinate timelines with cross-functional teams.

Skills

Data management

EDC systems

Project management

Client relations

Drug development knowledge

Education

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

Tools

CRF design

Data validation

Job description

MMS Holdings Inc in Bridgeport, CT is seeking an experienced Data Management Lead to drive study data integrity, regulatory compliance, and project success. This role requires strong leadership, deep knowledge of EDC systems, and the ability to guide data management activities across the lifecycle.

You will oversee end-to-end data management, mentor junior staff, and partner with clients and vendors to ensure timely delivery of clean datasets for regulatory submissions.