Senior Clinical Data Manager

The Senior Clinical Data Manager is responsible for all aspects of the data management process, from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine data review, through database lock of clinical trials. The Sr/CDM has a broad, fundamental knowledge of the data management process and can plan, manage, and coordinate all Data Management activities for assigned study(ies) with minimal guidance. This person may have project-level oversight of junior data managers and/or Clinical Data Associates (CDAs). The core duties and responsibilities of the Sr/CDM are delineated below. Duties and Responsibilities: Represents data management in study team meetings, able to facilitate and provide data management updates and/or input when appropriate. Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines. Generates and/or reviews/approves study documents (e.g., Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols). Reviews protocols for appropriate data capture, including electronic Case Report Form (eCRF) design and external data vendors' systems. Provides oversight of database set-up/migrations/updates, including coordinating and performing UAT. Leads the development of the internal Data Review Plan and coordinates the cross-functional team data listing review. Coordinates the internal medical coding review. Performs ad hoc and scheduled data listing review and generates/resolves queries in EDC. Performs Serious AE reconciliation according to SOPs and guidelines, as applicable. Executes and/or distributes data management metrics, listings, and reports. Provides oversight of data management CRO/service providers, including managing and monitoring the progress of data management activities with CROs and/or other service providers on assigned studies; builds effective relationships with CRO/service provider counterparts. Reviews and provides feedback to the clinical team on other study documents, e.g., Clinical Monitoring plans and vendor specifications. Provides training on the EDC system and/or CRF completion guidelines and the EDC system to internal or external study team members, as needed. Proactively identifies potential study issues/risks and recommends/implements solutions. Maintains study DM related documents/files for inspection readiness. Provides DM support to Statisticians and Statistical Programmers in the production of clinical trial reports and other deliverables. Assists with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies). Participates in the CRO/vendor selection process for outsourced activities. Supports budget and resource planning across assigned projects. Participates in the development, review, and implementation of departmental SOPs, templates, and processes. Participates in department or cross-functional initiatives (as needed). Contributes to a professional working environment through exemplifying our core values. Requirements and Qualifications: Bachelor's degree in health sciences, Life Sciences, Mathematics, Computer Sciences, or a health-related field. At least three years for CDM and five years for Sr. CDM of Data Management experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of minimum requirement. Requires solid knowledge of clinical data management principles, clinical trials process, and regulatory requirements. Good working knowledge of ICH, FDA, and GCP regulations and guidelines. Strong, well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint). Knowledge of industry standards (CDISC, SDTM, CDASH). Experience with web-based Electronic Data Capture (EDC), clinical data management systems, and industry-wide thesauri, such as MedDRA and WHO Drug. Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment. Ability to handle multiple projects and prioritize effectively, well organized, and detail-oriented. Proven ability to work both independently and in a team setting. Preferred Qualifications: Prior oncology/solid tumor experience highly desired. Working knowledge of statistical programming packages (e.g., SAS) is a plus. Desired Skills and Experience Clinical Data Management, Clinical Trials, Data Management Plans, eCRF Design, EDC Systems, Database Build and Lock, User Acceptance Testing, Clinical Data Review, Query Management, Data Reconciliation, SAE Reconciliation, Medical Coding, MedDRA, WHO Drug, CDISC, SDTM, CDASH, CRO and Vendor Management, Data Management Metrics and Reporting, Inspection Readiness, Risk Management, Regulatory Compliance, ICH-GCP, FDA Regulations, SOP Development, Budget and Resource Planning, SAS, Oncology, Cross-Functional Collaboration, Team Training and Oversight Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at #J-18808-Ljbffr