Sr. Clinical Data Manager
Company: Global Channel Management, Inc.
Location: East Orange
Posted on: March 18, 2019
Sr. Clinical Data Manager needs bachelors Degree with a proven level of relevant work experience in Clinical Research, Computer Science, Project Management Sr. Clinical Data Manager requires: Strong knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting). Strong knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials. Strong knowledge of global standards related to clinical data management activities (data standards, database design, coding and coding dictionaries, etc.). Excellent ability to work in a matrix environment and communicate effectively with different functional groups across the organization. Excellent ability to foster open communication and practice active listening to encourage a collaborative team environment. Demonstrates a solution oriented approach to problem solving and a can do attitude. Ability to travel up to 15% of time. Sr. Clinical Data Manager duties: Responsible for the role which includes the management and maintenance of clinical data and interfacing with clinical teams. Provides leadership and content expertise for Clinical Data Management activities from startup through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities. Member of the Protocol Review Team, CRF Review Team, Medical Safety Monitoring Plan Reviewer, member of the Clinical Study Report Review Team, and may perform peer review of Clinical Data Management deliverables as a Peer Data Management Lead. In addition, the incumbent is the key contact for Statistical Sciences and Programming (SSP), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology (GPSE), Clinical Development, and NonTranslational Sciences (NTS). Participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.) in accordance with applicable processes and procedures. Involvement in assessment/reassessment of vendor capabilities, as necessary. In addition, the incumbent is the key contact for R&D Sourcing and Clinical Vendor Oversight (CVO). The implementation of quality, efficient, and consistent approaches to carrying out Clinical Data Management tasks. Drives and contributes to continuous improvement. Delivering training to Clinical Data Management and other functions/departments as necessary. Monitors compliance to controlled procedural documents (e.g. SOPs) and proactively addresses gaps in processes or understanding of processes by Clinical Data Management staff. Supports Corrective and Preventative (CAPA) Action initiatives as needed.
Keywords: Global Channel Management, Inc., New York , Sr. Clinical Data Manager, Healthcare , East Orange, New York
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