Job Description

Overview Lead Clinical Data Manager role at Katalyst CRO. Responsible for the oversight of all data management CRO activities supporting the company\'s clinical programs from database start-up through database lock and CSR/submission. Serves as primary point of contact with the DM CROs, 3rd party vendors and internal study teams. Responsibilities Oversight of all data management CRO activities supporting company\'s clinical programs from database start-up through database lock and CSR/submission. Serve as primary point of contact with DM CROs, 3rd party vendors and internal study teams. Collaborate with internal team and DM CRO to develop study timelines and ensure all DM related deliverables are met. Oversee the development of the clinical database (DB), including user requirements, eCRF, edit rules/checks, data validation and User Acceptance Testing. Oversee development of key data management documents such as CRFs, data validation specifications, manual data review guidelines, CRF Completion Guidelines, programmable edit checks, Data Management Plans (DMP) and other related documents; ensure compliance with these study documents. Participate in the development of other study-related systems (e.g., ePRO, IVRS, Central lab, Central ECG). Oversee data cleaning activities including reconciliation with external databases. Review study statement of work, RFPs, budgets, and Change Orders. Collaborate with CROs to ensure clinical data within EDC and external data (e.g., ePRO; Labs) are of high quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock. Work with clinical programmers to create and implement oversight listings, reports, programming checks and/or patient profiles; perform internal data reviews during study conduct leading to database lock. Maintain internal Data Review Log and coordinate with DM vendors to resolve issues. Participate in review of clinical research documents (e.g., Protocols, Safety Monitoring Plans, Communication Plans). Review DM CRO metrics, reports, and reconciliation logs to ensure quality and timely escalation/resolution of issues. Develop, track, analyze and report on data management performance metrics from study start to database lock, as applicable. Troubleshoot data-related issues and provide immediate solutions. Create, present, and implement lessons learned related to DM activities for process improvement. Assist/participate in preparation and oversight of study audits/inspections (internal and external). Oversee all DM documents in the TMF/eTMF. Attend and present during Study Kick Off meetings and Investigator Meetings. Create and maintain meeting minutes for internal DM lead meetings/decision logs. Provide input during development and/or review of Data Management SOPs, Work Instructions and templates/standards in line with industry best practices and regulatory requirements. Requirements Bachelor\'s degree in a science-related field and/or computer systems/IT background. At least 8 years of data management experience in a pharmaceutical/Biotech or CRO environment. familiarity with CDISC/CDASH including the SDTM model. Familiarity with standard international coding dictionaries (e.g., WHODD, MedDRA). Familiarity with Pinnacle 21. Experience with Trial Master File (paper or electronic). Experience with various EDC software such as Medidata RAVE, Medrio, Oracle, Inform, Veeva CTMS and IXRS. Ability to handle multiple tasks and prioritize based on timelines; strong organizational and project management skills. Strong experience with Microsoft Word, Excel, PowerPoint, and other Microsoft tools. Experience working with CROs and with vendor oversight. Ability to interact effectively with Clinical Operations, Medical, Regulatory, Safety, Quality Assurance, Programming, and Biostatistics. Experience in clinical research across Phase I–IV studies. Excellent verbal and written communication, plus good organizational, interpersonal, and teamwork skills. Ability to work independently and report to the Director of DM; strong critical thinking and problem-solving skills. Working knowledge of Good Clinical Practices, clinical research processes and related regulatory requirements. Knowledge of regulatory agencies (FDA, EMA, PMDA) and audit experience is a plus. Seniority level Mid-Senior level Employment type Contract Referrals increase your chances of interviewing at Katalyst CRO. #J-18808-Ljbffr Katalyst CRO

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