Clinical Data Manager for Structural Heart Trials

4 C Medical Technologies; Maple Grove (MN); Vor Ort; USD 85.000 - 125.000; Vollzeit

Zusammenfassung

4 C Medical Technologies in Minnesota is seeking a Clinical Data Manager to lead day-to-day data management across the trial lifecycle for investigational structural heart studies. You will collaborate with cross-functional teams, oversee data cleaning, query resolution, database lock preparation, and ensure registry-quality data for regulatory submissions.

This role emphasizes ownership, accuracy, and adherence to ICH-GCP and FDA standards.

Qualifikationen

• Bachelor’s or Master’s degree in Life Sciences, Clinical Research, Statistics, Computer Science, or a related technical field.
• 3–6 years of experience in clinical data management, preferably within the medical device industry.
• Experience with EDC systems like Medidata Rave or CatchTrials, and familiarity with CRF/eCRF design.
• Knowledge of CDISC, CDASH, and SDTM standards.
• Familiarity with ICH-GCP, FDA 21 CFR Part 11, ISO 14155.
• Strong analytical and communication skills, detail-oriented.

Aufgaben

• Manage day-to-day data activities for assigned studies, ensuring alignment with study protocols, DM Plans, regulatory requirements, and procedures.
• Support development and maintenance of clinical databases, eCRFs, data management documentation, and related guidelines.
• Perform data cleaning, query management, data validation, reconciliation, and quality control.
• Monitor data quality, outstanding queries, discrepancies, and study timelines, escalate risks as needed.
• Support database lock preparation and execution, including data cleaning and issue resolution.
• Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Affairs, sites, and external vendors.
• Support EDC system activities, user acceptance testing, troubleshooting, and vendor coordination.
• Prepare and review clinical data listings, reports, data transfers for study reports and regulatory submissions.
• Maintain audit-ready documentation and support internal audits and inspections.
• Support compliance with FDA 21 CFR Part 11, ICH-GCP, ISO 14155.

Kenntnisse

Clinical data management

EDC systems

CDISC/CDASH/SDTM

SQL/SAS

Regulatory knowledge

Attention to detail

Communication

Multi-priority management

Ausbildung

Bachelor’s or Master’s degree in Life Sciences, Clinical Research, Statistics, Computer Science, or a related technical field

Tools

Medidata Rave

CatchTrials

Jobbeschreibung

4 C Medical Technologies in Minnesota is seeking a Clinical Data Manager to lead day-to-day data management across the trial lifecycle for investigational structural heart studies. You will collaborate with cross-functional teams, oversee data cleaning, query resolution, database lock preparation, and ensure registry-quality data for regulatory submissions.

This role emphasizes ownership, accuracy, and adherence to ICH-GCP and FDA standards.