Lead Clinical Data Manager CDM Strategy & Compliance

Katalyst CRO; City of Albany (NY); On-site; USD 120,000 - 190,000; Full time

Job summary

Katalyst CRO in Albany, NY seeks a senior CDM leader to direct clinical data management systems, oversee data collection, vendor oversight, and EDC builds across studies.

The role requires designing CRFs, data validation plans, SOPs, and managing CRO relationships, with focus on data integrity, regulatory compliance and timely study delivery. You will partner with cross-functional teams to ensure high data quality and regulatory readiness.

Qualifications

• Bachelor's Degree in scientific discipline; RN or advanced degree preferred.
• 9 years' CDM experience across study phases, with 5+ years in lead role for clinical development programs.
• Knowledge of CDM standards for medical devices (Class III PMA devices preferred).
• Experience in CRF/ eCRF design, DMPs, SDTM/ CDASH formats, and data management life cycle.

Responsibilities

• Provide leadership and strategic planning for clinical data management systems and vendor oversight.
• Oversee CDM activities from startup to archival; CRF/eCRF design; data validation specs; UAT and edit checks.
• Develop SOPs for CDM; manage DMPs, CRFs, and data quality review procedures.
• Produce study-level metrics and reconcile external data; drive performance improvements.

Skills

CDM leadership

data management

EDC systems

vendor management

regulatory knowledge

Education

Bachelor's Degree in scientific discipline

RN or advanced degree preferred

Tools

MedDRA

WHODrug

EDC tools

Job description

Katalyst CRO in Albany, NY seeks a senior CDM leader to direct clinical data management systems, oversee data collection, vendor oversight, and EDC builds across studies.

The role requires designing CRFs, data validation plans, SOPs, and managing CRO relationships, with focus on data integrity, regulatory compliance and timely study delivery. You will partner with cross-functional teams to ensure high data quality and regulatory readiness.