The Senior Data Manager brings advanced understanding of the clinical data management process from study start-up through database lock, including database design and data validation as per the requirements in the clinical study protocols, data review plan, & data management plan.
Provide UAT support of screens, edit checks, and dynamics.
Complete Query QC activities.
Support data cleaning, data reconciliation, and QC of data management documents.
Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
Acts as a process expert for operational and oversight models..
May prepare metrics to support the function’s KPIs.
Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of client.
Contributes 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.
Performs other duties as assigned.
100% Remote in India.
Bachelor's Degree in a science, health related, or information technology field required.
Minimum 6 years' experience in Clinical Data Management.
Excellent communication skills are a requirement.
Experience and understanding of data review listings and visualizations to include creation of specifications, presentation to cross functional team, and modification of specs to meet team requirements.
Experience with all phases of development in one or more therapeutic areas preferred.
Strong knowledge of data management best practices & 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 is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.
Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.
