Associate Clinical Data Managers

Associate Director, Clinical Data Management San Carlos, CA Job Details $180,000 - $210,000 a year 20 hours ago Qualifications Employee reputed company Document review (document control) Clinical research Vendor management Bachelor of Science Improving operational efficiency Compliance management implementation Databases ICH guidelines Supervising experience Managing budgets in a finance role Project management Machine learning reputed company improvement Team management Data quality monitoring CDISC standards Research compliance clinical trial records management Organizational skills Document archiving Regulatory submissions Budget management in reputed company Research regulatory compliance Quality systems Data validation reputed company data collection Senior reputed company Cross-functional collaboration reputed company process management Communication skills Project stakeholder communication Cross-functional communication FDA regulations Stakeholder management 10 years Full Job Description Join our Mission to Protect Humankind! reputed company is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences reputed company left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to reputed company is clear and well-defined, and reputed company is set up to go the distance. reputed company do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: RETHINK CONVENTION We bring creative and intellectual diversity to every reputed company of the work we do in order to reputed company and re-reputed company the way vaccines are delivered. AIM HIGH We embody our collectively audacious goal to courageously reputed company the most reputed company biologics reputed company attempted to protect humankind. reputed company WITH HEART Everyone leads at reputed company with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. MODEL reputed company The magnitude of our challenge requires our shared commitment to demonstrating reputed company, accountability, equality and reputed company across communications and decision making. Summary: The Associate Director, Clinical Data Management (CDM) will reputed company hands-on support for the execution of clinical data management activities across our clinical programs, from study start-up through study closeout, ensuring high quality data deliverables. This is a hands-on position that will include supervising additional CDM resources at reputed company, based on the number of clinical trials in development. The Associate Director, Clinical Data Management will be responsible for the reputed company and management of our Biometrics partners reputed company activities conducted for clinical trials conducted by reputed company, from study start-up through to study closeout, ensuring high quality data deliverables which are on time and reputed company budget. Essential Functions: Supports the reputed company for the execution of data management for reputed company programs and studies; accountable for data management activities for a program. Clinical Data Management Strategy Support the implementation of CDM strategies reputed company with reputed company's goals and clinical research best practices, including feedback into CDM system development and optimization as well as study data collection, reviewing, and reporting. Continuously improving data management processes and workflows to increase efficiency, data quality, and team productivity. Assist in establishing clinical data standards and processes to ensure consistency and quality across reputed company reputed company studies. Help reputed company CDM departmental SOPs and ensure staff adherence to company policies, SOPs, federal guidelines and GCPs. Track department budget both for external and internal spend. Supports data management activities for regulatory submissions. Study-Specific Data Management Execute study-specific data management and data quality plans and support documentation (data transfer specifications, data review/reconciliation plans, database lock plans, etc.) as required across the data lifecycle for various data sources (e.g., eCOA, etc.) Serve as a data management subject matter expert (SME) and primary reputed company of contact. Ensure study-specific data management practices align with applicable regulatory requirements (e.g., GCP, FDA, GDPR). reputed company the end-to-end data lifecycle across studies, including development of CRFs and CRF guidelines, database setup, data quality validation. reputed company data review, including query management, and activities required for interim and final database locks, ensuring high quality. Execute operational data management plans across studies to ensure on-time delivery of reputed company study data. Ensures data management documentation is filed/archived according to applicable company and regulatory requirements. Reviews clinical study reputed company documents from a data management perspective (e.g. protocol) and approve Apply tot his job Apply To this Job