Job Description Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you will be at the heart of our client's innovation. As a Senior Clinical Data Manager you will be dedicated to one of our global pharmaceutical clients—a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Responsibilities Lead or support data management study activities, CRO oversight, and driving deliverable timelines. Strong knowledge of EDC builds. Represent the 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. Contributes 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. Partner with stakeholders to resolve issues escalated from the vendor and/or cross‑functional teams. Participate in preparing the function for submission readiness and may represent the function in a formal inspection or audit. Participate and represent the function in formal inspections and 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 the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics. Be responsible for the planning and management of 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 the function’s 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. Qualifications Bachelor’s Degree in a science, health‑related, or information technology field required. Minimum 5 years of experience in Clinical Data Management. 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 processes. Strong knowledge of broad drug development process with expertise in the cross‑functional interfaces with the data management function. Equal Opportunity Statement We are an equal opportunity employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, national origin, age, disability, or any other protected status in accordance with applicable laws. #J-18808-Ljbffr