Clinical Data Manager

Job Overview
We are seeking a highly motivated and detail-oriented Clinical Data Manager to join our dynamic research team. In this vital role, you will oversee the collection, management, and validation of clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards. Your expertise will support the successful execution of clinical trials, contributing to groundbreaking medical advancements. This position offers an exciting opportunity to lead data management activities in a fast-paced environment dedicated to improving patient outcomes worldwide.

Duties

• Lead the design and development of clinical data collection tools, ensuring adherence to CDISC standards and regulatory requirements such as FDA regulations and ICH GCP guidelines.
• Supervise data management teams, providing guidance on data collection, entry, validation, and quality control procedures.
• Review clinical documentation including case report forms (CRFs), source documents, and laboratory reports for completeness and accuracy.
• Oversee the integration of electronic medical record (EMR) systems and other clinical laboratory information systems to streamline data flow.
• Monitor patient data including vital signs, blood sampling results, and other clinical measurements while ensuring compliance with HIPAA and patient confidentiality standards.
• Collaborate with clinical trial managers, statisticians, and medical staff to ensure timely data collection and resolution of discrepancies.
• Conduct training sessions on clinical trials management protocols, medical terminology, and compliance requirements for team members.
• Maintain detailed documentation of all data management activities for audit readiness and regulatory submissions.

Experience

• Proven supervising experience in a clinical research or data management setting with demonstrated leadership capabilities.
• Extensive knowledge of clinical trials management processes from study start-up through close-out phases.
• Strong understanding of medical terminology, clinical laboratory procedures, and patient monitoring techniques.
• Hands-on experience with statistical software used in clinical research analysis.
• Familiarity with FDA regulations, ICH GCP guidelines, HIPAA compliance standards, and CDISC standards for data interchange.
• Clinical laboratory experience or nursing background is highly desirable to enhance understanding of sample collection and analysis procedures.
• Proficiency in EMR systems, blood sampling techniques such as phlebotomy, and vital signs measurement is preferred.
• Certification in ICH GCP from a recognized issuer is required; valid certification from a CA-approved issuer is advantageous.
• Strong analysis skills with the ability to interpret complex datasets accurately while maintaining meticulous documentation throughout the research process. Join us to be part of a passionate team dedicated to advancing healthcare through innovative clinical research!

Pay: $60,000.00 - $65,000.00 per year

Work Location: In person