Senior Clinical Data Manager — Lead CDM Projects & Compliance

MMS Holdings Inc; Jersey City (NJ); Remote; USD 115,000 - 165,000; Full time

Job summary

MMS Holdings Inc is a data-focused clinical research organization (CRO) offering opportunities in data management leadership in Jersey City, NJ. The team supports pharmaceutical, biotech, and medical device trials with a scientific approach to complex data and regulatory challenges.

Role involves overseeing data management from study setup to close-out, mentoring junior data managers, and collaborating with cross-functional teams to ensure timely delivery and regulatory compliance in a

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

• Confidently displays excellent internal and external customer service.
• Advises customers on best-fit EDC solution using knowledge of multiple EDC systems.
• Interact with DM suppliers and clients to coordinate projects and maintain relationships.
• Oversee data management from study setup to close-out and serve as primary DM contact.
• Lead protocol reviews with clients and suggest how to capture data in databases.
• Ensure compliance with GCP/ICH and FDA data management regulations.

Skills

Customer service

EDC systems

Data governance

GCP/ICH/FDA

Project leadership

Education

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

Tools

EDC systems

CRF study systems

CDM tools

Job description

MMS Holdings Inc is a data-focused clinical research organization (CRO) offering opportunities in data management leadership in Jersey City, NJ. The team supports pharmaceutical, biotech, and medical device trials with a scientific approach to complex data and regulatory challenges.

Role involves overseeing data management from study setup to close-out, mentoring junior data managers, and collaborating with cross-functional teams to ensure timely delivery and regulatory compliance in a