Senior Clinical Data Manager - CDM Strategy & EDC Lead

Katalyst CRO; Edison (NJ); On-site; USD 140,000 - 210,000; Full time

Job summary

Katalyst CRO is seeking a senior CDM leader to drive clinical data management across studies. You will oversee CRF design, data validation plans, and eCRF testing, while coordinating with vendors and cross-functional partners to meet regulatory standards.

Ideal candidates have extensive CDM experience in medical device programs, strong GCP/ICH/FDA knowledge, and a track record of delivering data quality and timely study milestones.

Qualifications

• Bachelor's degree in a scientific discipline; RN or higher degree preferred.
• 9 years’ CDM experience across all study phases; 5+ years in lead roles for medical devices.
• Strong knowledge of CDM standards for medical devices; FDA guidance familiarity.
• Proven ability to manage complex CDM projects to FDA filing/approvals.
• Expertise in CRF design, data management, SDTM/CDASH formats.

Responsibilities

• Provide leadership and strategic planning for clinical data management systems.
• Oversee CDM activities from study startup to archival; ensure data integrity.
• Develop SOPs/DM plans and oversee eCRF completion testing.
• Generate study metrics and reconcile external data; drive process improvements.
• Evaluate CROs and external vendors; ensure adherence to quality standards.
• Collaborate with cross-functional teams to meet regulatory requirements.

Skills

CDM leadership

EDC build

Vendor management

Regulatory knowledge

GCP/ICH/FDA knowledge

Data quality oversight

Cross-functional collaboration

Education

Bachelor's degree in science

RN or advanced degree preferred

Tools

MedDRA

WHO Drug Dictionary

CRF/EDC concepts

Job description

Katalyst CRO is seeking a senior CDM leader to drive clinical data management across studies. You will oversee CRF design, data validation plans, and eCRF testing, while coordinating with vendors and cross-functional partners to meet regulatory standards.

Ideal candidates have extensive CDM experience in medical device programs, strong GCP/ICH/FDA knowledge, and a track record of delivering data quality and timely study milestones.