Senior Clinical Data Manager at Cytel Sacramento, CA

Senior Clinical Data Manager – Cytel, Sacramento, CA Responsibilities Lead data management study activities, CRO oversight, and drive deliverable timelines. Represent data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and client for all data‑related deliverables, especially in support of key decision points and regulatory submissions. Contribute influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality. Partner with appropriate stakeholders and CRO partners to mitigate and resolve risks. Provide input to functional governance with client strategic suppliers. Resolve issues escalated from the vendor and/or cross‑functional teams. Participate in preparing function for submission readiness and represent the function in formal inspections or audits as requested. Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. Ensure achievement of major data management deliverables and milestones in coordination with other functions including Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics. Plan and manage external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. Act as a process expert for operational and oversight models. Maintain SOPs, process maps and templates and timelines to support functions operational and oversight models. Prepare metrics to support the function's KPIs. Represent the function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of the client. Contribute to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements. Ensure compliance with own Learning Curricula, corporate and/or GXP requirements. Work cross‑functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables. Perform other duties as assigned. Qualifications Proven recent experience as a Lead Clinical Data Manager with substantial RAVE experience. Bachelor's Degree in a science, health‑related, or information technology field required. Minimum 6 years experience in Clinical Data Management with at least 2 as a Lead. Experience with all phases of development in one or more therapeutic areas preferred. Strong knowledge of data management best practices and technologies as applied to clinical trials. Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. Strong knowledge of broad drug development process with expertise in the cross‑functional interfaces with the data management function. Cytel Inc. is an Equal Employment / Affiliated Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law. #J-18808-Ljbffr