Lead or support data management study activities, CRO oversight, and driving deliverable timelines.
Strong knowledge of EDC builds.
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.
Bachelor's Degree in a science, health related, or information technology field required.
Minimum 5 years 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 & 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.
Skills Required
- Bachelor's degree in science, health-related, or information technology
- Minimum 5 years experience in Clinical Data Management
- Strong knowledge of EDC builds
- Strong knowledge of data management best practices and technologies for clinical trials
- Solid understanding of clinical trial documents (protocols, SAPs, CRFs, study reports) and processes
- Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and management
- Knowledge of GxP requirements and compliance
- Experience with all phases of development in one or more therapeutic areas
- Experience with CRO oversight, vendor management, and budget/timeline management
Cytel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cytel and has not been reviewed or approved by Cytel.
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Healthcare Strength — Health coverage is described as comprehensive, spanning medical, dental, vision, life and disability, with FSAs/HSAs also available. Plan quality is often characterized as good to excellent, which lifts the perceived value of the overall package.
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Retirement Support — A 401(k) with employer match is consistently part of the benefits package. The plan is also characterized as well managed, contributing to a sense of baseline retirement support.
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Fair & Transparent Compensation — Overall pay is characterized as decent-to-good and broadly competitive in parts of the business, with stronger alignment noted in senior technical tracks like biostatistics and programming. The total package is often framed as respectable rather than premium.
Cytel Insights
What We Do
Cytel enables decision-makers in the life sciences to unlock the full potential of their products. From navigating uncertainty to proving value, Cytel’s 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical companies transform intelligence into confident decisions. We have an uncompromising commitment to scientific rigor and high standards of operational excellence, which are channeled through our locations in North America, Europe, the United Kingdom, and Asia. Together, we enable our clients to deliver the therapies that propel humanity forward. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably best known for being leaders in the field of adaptive clinical trial design, a subset of trial design that uses interim looks to enhance the patient safety and commercial value of pharmaceutical products. We also have specialists in Bayesian statistics, real world evidence, artificial intelligence, health economics, and a number of other research fields to ensure that academic and scientific findings can have impact on industry quickly and seamlessly. www.cytel.com
