Cytel
Cytel
About the job
Responsibilities
Responsible for independently leading data management study activities, CRO oversight, and driving deliverable timelines.
Strong knowledge of EDC builds utilizing RAVE.
Represents 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.
Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
Provides input to functional governance with client strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
Participates and represents function in formal inspections and audits as requested.
Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
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.
Acts as a process expert for operational and oversight models.
Maintains SOPs, process maps and templates and timelines to support functions 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.
Works 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.
Performs 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 IT field.
Minimum 6 years’ experience in Clinical Data Management at the CRO or pharma level.
2 years as a CDM lead.
Experience with all phases of development.
Strong knowledge of data management best practices and technologies.
Senior Clinical Data Manager
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.