Clinical Data Manager Full-time Job

The Clinical Data Manager I (CDM) leads and coordinates Data Management (DM) activities from database design & set-up, clinical data manager through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.clinical data manager The CDM I works on studies with minimal supervision from a CDM II or senior CDM. The CDM I is a member of the Data Management staff.clinical data manager • Serve as primary contact for DM with all relevant parties both internally (e.g. Project Management, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, external vendors, investigational sites clinical data manager • Plan and project the resources required including management of tasks, timelines, risk and quality clinical data manager • Keep track on budget, forecasts and manage changes of scope requests • Participate in the review of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan) clinical data manager• Provide support on clinical study database set-up, including eCRF design and database validation requirements • Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements • Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks • Create training materials for EDC users and provide project-specific training as required • Review and validate clinical data to ensure consistency, accuracy, integrity and completeness • Create data cleaning plan in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock) • Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance etc. • Perform and/or coordinate various data transfers and data reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data • Assist in medical coding tasks as assigned • Assist in training of other DM personnel and project teams • Help to align data management and clinical programming best practices, standards and conventions within the company • Explore and propose initiatives for improving efficiency • Participate in internal and external audits clinical data manager • Maintain documentation on an ongoing basis and ensure that all filing is up to date • Manage the database implementation, lock and close-out processes and procedures • Recognize and solve potential problems and evaluate effectiveness clinical data manager • Participate in conference calls and/or meetings with vendors and sponsors Requirements Qualifications • Life science, healthcare and/or related field degree • Minimum 1-5 years of relevant work experience • Minimum 1-5 years of experience in drug development and/or clinical research • Basic knowledge of ICH-GCP(R2), GDPR/HIPAA and applicable (local) regulatory requirements • Good understanding of CDISC data conventions