Sr. clinical Data Manager

Katalyst CRO; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO, located in Irvine, California, is seeking an experienced Clinical Data Manager to provide leadership in clinical systems for data collection. The role encompasses responsibilities from study startup to archival processes, requiring strong expertise in clinical data management standards and FDA regulations.

The ideal candidate will possess at least 9 years of industry experience and demonstrate a proven track record in managing complex clinical development programs. Exceptional leadership and communication skills are essential.

Qualifications

• Bachelor's degree in scientific discipline; RN or advanced degree preferred.
• 9 years of industry experience in CDM with at least 5 years in a lead role.
• Thorough knowledge of CDM standards for medical devices.

Responsibilities

• Provide leadership and implementation of clinical systems for data collection.
• Manage all CDM activities from study startup to closeout.
• Collaborate with cross-functional teams to implement CDM standards.

Skills

Clinical data management (CDM)

Leadership

Project management

Communication skills

Data analysis

Education

Bachelor's Degree in scientific discipline

Tools

EDC systems

Clinical study databases

MedDRA and WHO Drug coding

Job description

Responsibilities

• Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc.
• Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO Drug; and complete database lock, archival, and closeout activities
• Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks
• Provide study level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities
• Collaborate with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations, manage and oversee all phases of data management activities
• Provide program/study level oversight and expertise for CDM activities for multiple studies
• Review clinical data on an ongoing basis to ensure consistency, integrity and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns
• Establish external data reconciliation processes; develop CDM processes for management and determination of adjudication for independent review of video-endoscopies, CT scans
• Evaluate and manage CROs and external technology vendors to meet company's goals and CDM standards
• Build and drive positive relationships and teamwork within the clinical team and partnering sites with professional demeanor
• Make decisions and chart course through careful evaluation of risks and benefits with limited information in conjunction with leadership; serve as the interdepartmental subject matter expert for the CDM area
• Evaluate and manage CROs and external technology vendors to meet company's goals and clinical data management quality standards on an ongoing basis
• Assist with routine quality audits as applicable

Requirements

• Bachelor's Degree in scientific discipline (RN or advanced degree preferred)
• 9 years' industry experience in CDM in all study phases and activities from startup to archival with at least 5 years in lead role for clinical development programs with medical devices leading toward FDA filing / approvals
• Thorough knowledge of the CDM standards for medical devices (Class III PMA devices preferred)
• Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats
• Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials
• Working knowledge of the MedDRA and WHO Drug dictionary coding terms Able to complete tasks independently, accurately and efficiently with attention to detail and in a timely manger
• Experience in implementing, validating, and administrating other clinical systems for data collection (e.g., eSource, IVRS, IWRS, core lab web-based portals)
• Demonstrated ability to manage complex projects with tight timelines and overcome project roadblocks
• Excellent verbal and written communication skills