Bachelor's Degree in scientific discipline (RN or advanced degree preferred)
9 years' experience in clinical data management (CDM) across all study phases
Minimum of 5 years in a lead role for clinical development programs for medical devices
Thorough knowledge of CDM standards for medical devices, especially Class III PMA devices
Expertise in clinical study database management from design to lock procedures
Working knowledge of GCP, ICH, and FDA regulations for clinical trials
Experience implementing and managing clinical systems for data collection
Responsibilities
Provide strategic leadership and direction for clinical systems and data collection
Oversee all CDM activities from study startup to archival and ensure data quality
Develop and manage standard operating procedures (SOPs) for clinical data management
Provide study level metrics and translate data into performance assessments
Collaborate with cross-functional teams to implement CDM processes and standards
Review clinical data for consistency and integrity, addressing compliance concerns
Evaluate and manage CROs and technology vendors to ensure compliance and quality
Benefits
Comprehensive health insurance plans
401(k) retirement plan with company matching
Generous paid time off and holiday policy
Professional development and continuing education opportunities
Flexible working hours and remote work options
Full 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 data base 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
