Bachelor's Degree in scientific discipline (RN or advanced degree preferred)
9 years' industry experience in clinical data management (CDM), with at least 5 years in a lead role for clinical development programs, particularly for medical devices
Thorough knowledge of CDM standards for Class III PMA devices
Expertise in clinical study database development, validation, and management throughout its lifecycle
Working knowledge of GCP, ICH, and FDA regulations for clinical trials
Familiarity with MedDRA and WHODrug coding terms
Proven experience in managing complex projects with tight timelines.
Responsibilities
Lead and implement clinical systems for data collection, including vendor selection and budget oversight.
Oversee all CDM activities from study startup to archival, ensuring data integrity and compliance.
Create and manage standard operating procedures for CDM, including Data Management Plans and eCRF specifications.
Analyze and report on study level metrics and reconcile external data to ensure quality compliance.
Collaborate with cross-functional teams to enhance CDM processes and maintain regulatory standards.
Provide oversight for multiple clinical studies, ensuring alignment with quality and performance metrics.
Continuously review clinical data to identify issues that could impact study compliance.
Benefits
Opportunity to work on cutting-edge medical device development.
Collaborative work environment with cross-functional team involvement.
Access to professional development and training resources.
Engagement in meaningful projects that contribute to patient safety and regulatory approvals.
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
ssist 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 WHODrug 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.
