Katalyst CRO
Lead Clinical Data Manager – Katalyst CRO
Join to apply for the Lead Clinical Data Manager role at Katalyst CRO. Overview Oversee all data management CRO activities supporting the company’s clinical programs from database start-up through database lock and CSR/submission. Serve as the primary point of contact with DM CROs, 3rd party vendors and internal study teams. Responsibilities Develop study timelines with internal teams and the DM CRO to ensure all data management 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 the 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 (ePRO, IVRS, Central lab, Central ECG, etc.). Oversee all study-related data cleaning activities including reconciliation with external databases. Review the study statement of work, RFPs, budgets, and Change Orders. Ensure high-quality clinical data within EDC and external data (e.g., ePRO, labs) for appropriate database lock decisions (lock/unlock, freeze/unfreeze) for statistical review, interim review, and final database lock. Collaborate with clinical programmers to create and implement oversight listings, reports, programming checks and patient profiles; regularly review data during study conduct leading to database lock. Maintain the Internal Data Review Log and work with DM vendors to resolve issues. Review various clinical research documents (Protocols, Safety Monitoring Plans, Communication Plans) and DM CRO metrics, reports, and reconciliation logs to ensure quality and timely issue escalation/resolution. Develop, track, analyze and report on data management performance metrics from study start to database lock; troubleshoot data-related issues and implement 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 at Study Kick Off and Investigator Meetings; maintain meeting minutes and decision logs. Provide input during development and review of Data Management SOPs, Work Instructions and templates/standards, incorporating 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 (SDTM model) and standard international coding dictionaries (e.g., WHODD, MedDRA). Familiarity with Pinnacle 21 and Trial Master File (TMF) management (paper or electronic). Experience with EDC systems (e.g., Medidata RAVE, Medrio, Oracle, Inform, Veeva CTMS) and IXRS. Strong organizational and project management skills with the ability to handle multiple tasks and prioritize by timelines. Proficiency in Microsoft Word, Excel, PowerPoint and related tools; experience working with CROs and in vendor oversight. Ability to interact effectively with Clinical Operations, Medical, Regulatory, Safety, Quality Assurance, Programming, and Biostatistics functions. Experience in clinical research across Phase I–IV trials; excellent verbal and written communication, interpersonal and teamwork skills. Ability to work independently and report to the Director of DM; strong problem-solving and critical-thinking abilities. Working knowledge of Good Clinical Practices, clinical trial processes, regulatory requirements, and terminology; knowledge of FDA/EMA/PMDA and audit experience is a plus. Seniority level Mid-Senior level Employment type Contract Job function Information Technology Industries Pharmaceutical Manufacturing
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Join to apply for the Lead Clinical Data Manager role at Katalyst CRO. Overview Oversee all data management CRO activities supporting the company’s clinical programs from database start-up through database lock and CSR/submission. Serve as the primary point of contact with DM CROs, 3rd party vendors and internal study teams. Responsibilities Develop study timelines with internal teams and the DM CRO to ensure all data management 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 the 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 (ePRO, IVRS, Central lab, Central ECG, etc.). Oversee all study-related data cleaning activities including reconciliation with external databases. Review the study statement of work, RFPs, budgets, and Change Orders. Ensure high-quality clinical data within EDC and external data (e.g., ePRO, labs) for appropriate database lock decisions (lock/unlock, freeze/unfreeze) for statistical review, interim review, and final database lock. Collaborate with clinical programmers to create and implement oversight listings, reports, programming checks and patient profiles; regularly review data during study conduct leading to database lock. Maintain the Internal Data Review Log and work with DM vendors to resolve issues. Review various clinical research documents (Protocols, Safety Monitoring Plans, Communication Plans) and DM CRO metrics, reports, and reconciliation logs to ensure quality and timely issue escalation/resolution. Develop, track, analyze and report on data management performance metrics from study start to database lock; troubleshoot data-related issues and implement 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 at Study Kick Off and Investigator Meetings; maintain meeting minutes and decision logs. Provide input during development and review of Data Management SOPs, Work Instructions and templates/standards, incorporating 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 (SDTM model) and standard international coding dictionaries (e.g., WHODD, MedDRA). Familiarity with Pinnacle 21 and Trial Master File (TMF) management (paper or electronic). Experience with EDC systems (e.g., Medidata RAVE, Medrio, Oracle, Inform, Veeva CTMS) and IXRS. Strong organizational and project management skills with the ability to handle multiple tasks and prioritize by timelines. Proficiency in Microsoft Word, Excel, PowerPoint and related tools; experience working with CROs and in vendor oversight. Ability to interact effectively with Clinical Operations, Medical, Regulatory, Safety, Quality Assurance, Programming, and Biostatistics functions. Experience in clinical research across Phase I–IV trials; excellent verbal and written communication, interpersonal and teamwork skills. Ability to work independently and report to the Director of DM; strong problem-solving and critical-thinking abilities. Working knowledge of Good Clinical Practices, clinical trial processes, regulatory requirements, and terminology; knowledge of FDA/EMA/PMDA and audit experience is a plus. Seniority level Mid-Senior level Employment type Contract Job function Information Technology Industries Pharmaceutical Manufacturing
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