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 demeanour.
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.
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 manner.
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.
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