Senior Clinical Data Manager

🔥 12 hours ago

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Direct CDM team activities to complete project deliverables on schedule, within quality standards, requirements, and budget from study start-up through archival • Serve as CTI CDM representative on project teams • Recommend work-process improvements and respond to questions about CDM processes, timelines, and data quality • Maintain relationships with internal customers and sponsors, providing project updates and coordinated plans • Establish CDM deliverables, time estimates, data-cleaning guidelines, conventions, GSOPs, workflows, and related processes • Monitor timelines, enrollment, data collection, quality, GSOP compliance, workflow, and project budgets • Identify out-of-scope activities and manage sponsor or management approvals and cost documentation • Provide or arrange project-specific training and mentor lower-level Clinical Data Managers • Develop accurate project reports for sponsors, project teams, and CTI management • Coordinate receipt, handling, and reconciliation of external data sources including central laboratory, ECG, and serious adverse events data • Prepare for and participate in meetings, complete action items, and provide input • Maintain study documentation and CDM project plans reflecting deviations and scope changes • Conduct post-mortem analyses and provide study metrics to CDM management

🎯 Requirements

• Bachelor’s degree in nursing or life science and/or equivalent combination of education and clinical research experience • Minimum 5 years of related Clinical Data Manager experience in either pharmaceutical or CRO environment • 2 years of relational database experience • Experience with Medidata Rave or OmniComm, TrialMaster • Excellent verbal and written communication skills • Knowledge of regulatory guidelines • Knowledge regarding medical terminology and drug nomenclature • Knowledge of the drug development and clinical research process