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Senior Manager of Clinical Data Management

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Irvine, CA

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Senior Manager of Clinical Data Management
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Irvine
CA
Job #700761247
SENIOR MANAGER OF CLINICAL DATA MANAGEMENT IRVINE, CA Project Description: The Senior Manager, Clinical Data Management is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan, coordination of Centralized Data Review activities (a key component of Risk-Based Monitoring), and is accountable for data integrity, quality, and consistency at Database Lock. The employee must be able to lead data review activities and engage different functional groups leading to active participation in ensuring data integrity and completeness. Other responsibilities include contribution to the definition of defined company data standards and conventions. Functioning as an advisor for Clinical Data Management activities to all project teams. Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices. May contribute to department and other project budget planning. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Client policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections. Participate in protocol review and CRF design (paper or eCRF). Write edit check specifications and test edit checks. Perform user acceptance testing on database applications and data transfers. Generate, process, track and resolve queries. Prepare Data Management Plans. Perform SAE reconciliation between the clinical database and the Drug Safety database. Perform external data reconciliation. Close study database based on pre-defined criteria as per timelines. Assist in defining and the follow-up of milestones and timelines. Lead various data management meetings for CRF development, e-Help, edit checks with study team. Train sites at investigator meetings and data management staff on study database. Provide support to data management staff over the course of the study. Represent Data Management as the lead contact and liaison on the clinical study team. This position reports to the Executive Director of Clinical Data Management. 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 start-up 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 Non-Translational Sciences (NTS). Participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.) in accordance with applicable Client processes and procedures. Involvement in assessment/re-assessment 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. Required Skills: Bachelor's Degree with a proven level of relevant work experience in Clinical Research, Computer Science, Project Management or related field. 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. This 12 month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ~~~ ALPHA'S REQUIREMENT #18-00965 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Updated 07/13/2018
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