Sr.Clinical Data Manager

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 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 courses 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 :