Senior Clinical Data Manager: Strategy & CDM Oversight

Katalyst CRO; Philadelphia (Philadelphia County); On-site; USD 140,000 - 190,000; Full time

Job summary

Katalyst CRO is seeking an experienced CDM leader to drive data management strategies and governance for multiple clinical studies in the medical device space. You will oversee CRF design, data quality, and vendor management while aligning with GCP/ICH/FDA guidelines.

The role requires a strong track record in CDM leadership, SOP development, and experience with MedDRA/WHODrug Coding, with emphasis on Class III PMA devices. On-site in the United States preferred.

Qualifications

• Bachelor's Degree in scientific discipline (RN or advanced degree preferred).
• 9 years' industry experience in CDM across all study phases and activities.
• Lead role experience totaling at least 5 years in clinical development programs with medical devices toward FDA filings/approvals.
• Thorough knowledge of CDM standards for medical devices (Class III PMA devices preferred).
• Expertise in development, validation, and management of the clinical study database lifecycle, including CRF design, DB development and SDTM/CDASH.
• Working knowledge of GCP, ICH and FDA guidance and regulations for clinical trials.
• Experience with MedDRA and WHODrug terminology coding.

Responsibilities

• Provide leadership, strategic planning, direction, and implementation of clinical systems for data collection.
• Oversee CDM activities from study startup to archival: CRFs/eCRFs, DMPs, eCRF guidelines, and data review plans.
• Develop and manage SOPs for clinical investigation data management; DMPs, eCRFs, UAT plans and scripts.
• Provide study-level metrics and data reconciliation processes; translate metrics into performance insights.
• Collaborate with cross-functional teams to implement CDM processes and meet quality regulations.
• Provide program/study level CDM oversight for multiple studies.
• Review clinical data to ensure consistency, integrity, and accuracy; identify data issues.
• Establish external data reconciliation processes for adjudication of video-endoscopies, CT scans.
• Evaluate and manage CROs and external technology vendors to meet CDM standards.
• Build strong relationships within the clinical team and partnering sites.

Skills

CDM leadership

Regulatory knowledge

GCP/ICH/FDA

Project management

Data management

Communication

Education

Bachelor's Degree in scientific discipline

RN or advanced degree preferred

Job description

Katalyst CRO is seeking an experienced CDM leader to drive data management strategies and governance for multiple clinical studies in the medical device space. You will oversee CRF design, data quality, and vendor management while aligning with GCP/ICH/FDA guidelines.

The role requires a strong track record in CDM leadership, SOP development, and experience with MedDRA/WHODrug Coding, with emphasis on Class III PMA devices. On-site in the United States preferred.