Responsibilities: Support the Lead Data Manager across one or more clinical studies. Reviews protocols for appropriate data capture including electronic (eCRF) design. Support CRF design, review, and validation of clinical database. Provide expertise and support oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing. Reviews or generates study documents (Data Management Plan, CRF Completion Guidelines, DB build specifications, Edit Check Specifications, Data Transfer Specifications, SAE and/or External Data Reconciliation Plans, Coding Guidelines, Vendor Management Plans, etc.) Review CRF metrics reports against project data deliverables. Conducts oversight of data management vendors via ongoing review of quality and performance metrics. Leads the Data Review plan check, specification and validation updates. Facilitates and participates in scheduled and ad hoc data listing review. Generates, resolves, and tracks data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications. Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables. Reviews and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications. Maintains study DM related documents/files for inspection readiness. Conducts the SAE and external vendor data reconciliation. Review and may distribute/coordinate data management metrics, listings, and reports. Responsible for maintaining internal data management timelines and metrics. Maintains study DM related documents/files for inspection readiness. Proactively identifies potential data management issues/risks and communicates it within the study team for further action. Participate in process improvement activities resulting in increases in productivity, quality, and/or cost effectiveness.Requirements: Minimum BA/BS in scientific or health-related field. Minimum of 9-11 years of clinical data management experience in the pharmaceutical and biotechnology industry or in a CRO. At least 1 year experience working at a Sponsor. Oncology trial experience required; hematology/oncology preferred. Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to DM practice. Proficient with Medidata RAVE. Experience with working on Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred. Familiarity with various data visualization, analytics, and reporting tools is a plus. Excellent communication skills (verbal and writing). Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting. Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.). Strong organizational skills and ability to prioritize tasks. Proven ability to work independently and in a team setting. Katalyst Healthcares and Life Sciences
...limited to, supporting all staffing and recruitment functions. AG offers a comprehensive benefit... ...the Sworn Recruitment initiative. Coordinate and monitor a variety of administrative... ...onsite, full-time, in Downtown DC. No remote support is permitted. Must be able to...
...Field Electrical Controls Engineer Needed for Growing Machine Safety Guarding Company!! This Jobot Job is hosted by: Bryce Koelsch Are you a fit? Easy Apply now by clicking the Apply button and sending us your resume. Salary: $90,000 - $115,000 per year A...
...Job Summary We are seeking a detail-oriented and experienced bookkeeper to manage core financial tasks and support our business... ...but not required. Benefits Competitive salary Remote work for flexibility, comfort, and savings on commuting Startex...
...looking for a place to call home? Stability? A Career? Come join the SYGMA Portland Team and get paid what youre worth. Our Delivery Drivers run 3-4 routes per week and average $90,000 per year with potential to earn over $100,000! At SYGMA we value our people and...
...Position: Payroll Specialist Location: Lone Tree, CO We are proud to partner with a consulting firm in Lone Tree for a Payroll Specialist to join their payroll division. The Payroll Specialist is tasked with ensuring the precise and prompt execution of all payroll...