Senior Clinical Data Manager - Lead End-to-End CDM

MMS; Philadelphia (Philadelphia County); On-site; USD 120,000 - 160,000; Full time

Job summary

MMS is a recognized, data-focused clinical research organization committed to delivering quality data management and regulatory support. We seek a senior data management professional to lead study data management from setup through close-out, collaborating with sponsors, DM staff, and cross-functional teams.

You will oversee data handling, CRF design, QCs, validation checks, and UAT coordination while mentoring junior staff and ensuring GCP/ICH compliance with 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 a minimum of 1 year leading projects.
• Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems.
• Excellent verbal and written communication skills, as well as interpersonal and organizational skills.

Responsibilities

• Confidently displays excellent internal and external customer service.
• Has proficiency and knowledge of multiple EDC systems; advises customers regarding best-fit EDC solution.
• Interacts directly with DM suppliers including EDC/IWR; negotiates with supplier to meet business needs as required.
• Interacts directly with clients to coordinate all facets of projects; builds and maintains strong client contacts and relationships.
• Responsible for data management from study setup to close-out; primary contact on study-specific issues; understands drug development related to data management.

Skills

Customer service

EDC systems

Data management

Project leadership

GCP/ICH knowledge

FDA regulations

Training

Education

Bachelor's or Master's in scientific/healthcare

Tools

CRF/EDC tools

Job description

MMS is a recognized, data-focused clinical research organization committed to delivering quality data management and regulatory support. We seek a senior data management professional to lead study data management from setup through close-out, collaborating with sponsors, DM staff, and cross-functional teams.

You will oversee data handling, CRF design, QCs, validation checks, and UAT coordination while mentoring junior staff and ensuring GCP/ICH compliance with FDA regulations.