Senior Clinical Data Manager — CDM Lead & Data Integrity

Katalyst CRO; Boston (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO seeks an experienced Clinical Data Management professional to lead data collection systems and oversee CDM activities across multiple studies. You will design CRFs/eCRFs, set data standards, and manage vendor relationships to ensure data integrity and regulatory compliance.

The role requires extensive CDM experience, strong regulatory knowledge, and the ability to drive timelines and quality across diverse studies.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• 9+ years in CDM across all study phases with lead exposure for medical devices preferred.
• Thorough knowledge of CDM standards for medical devices (Class III PMA devices preferred).
• Expertise in study database development, validation, testing, and data quality review.
• Strong knowledge of GCP, ICH and FDA guidance and regulations for trials.
• Ability to manage complex projects with tight timelines and roadblocks.
• Experience implementing and administering clinical data collection systems (eSource, IVRS/IWRS).

Responsibilities

• Provide leadership and strategic direction for clinical data management systems and CDM processes.
• Oversee CDM activities from startup to archival, including CRF/eCRF design and data plans.
• Develop SOPs, DMPs, UAT plans and scripts, and EDC edit checks.
• Produce study-level metrics and data reconciliation with vendors and sites.
• Collaborate with cross-functional teams to ensure quality and regulatory compliance.
• Provide program-level CDM oversight across multiple studies.
• Review data for consistency, integrity, and quality; identify trends or issues.
• Establish external data reconciliation processes for adjudication (e.g., video-endoscopies, CT scans).
• Evaluate CROs and vendors to ensure alignment with CDM standards and goals.
• Build positive relationships within clinical teams and partner sites.

Skills

CDM leadership

Data management

EDC build & study timelines

Vendor oversight

Budgeting & planning

Regulatory knowledge

MedDRA/WHO Drug coding

GCP/ICH/FDA

Project management

Staff oversight

Education

Bachelor's Degree in scientific discipline

Advanced degree preferred

Tools

EDC systems

MedDRA/WHODrug coding

Job description

Katalyst CRO seeks an experienced Clinical Data Management professional to lead data collection systems and oversee CDM activities across multiple studies. You will design CRFs/eCRFs, set data standards, and manage vendor relationships to ensure data integrity and regulatory compliance.

The role requires extensive CDM experience, strong regulatory knowledge, and the ability to drive timelines and quality across diverse studies.