Senior Clinical Data Manager

This is a fully remote position, open to applicants in Kentucky.

📋 Description

• Oversee the activities of the CDM team to ensure project deliverables are completed on time, adhering to quality standards, requirements, and budget from the start of the study to archival.

• Act as the CDM representative for CTI on project teams.

• Suggest improvements to work processes and address inquiries related to CDM procedures, timelines, and data quality.

• Foster relationships with internal clients and sponsors by providing project updates and coordinated plans.

• Define CDM deliverables, estimate timelines, establish data-cleaning guidelines, conventions, GSOPs, workflows, and associated processes.

• Track timelines, enrollment, data collection, quality, adherence to GSOP, workflow, and project budgets.

• Recognize activities that fall outside the project scope and manage approval processes with sponsors or management, including cost documentation.

• Provide or arrange for training specific to the project and mentor junior Clinical Data Managers.

• Create accurate project reports for sponsors, project teams, and CTI management.

• Manage the receipt, handling, and reconciliation of external data sources, which include central laboratory, ECG, and serious adverse events data.

• Prepare for and engage in meetings, complete assigned action items, and contribute insights.

• Maintain study documentation and CDM project plans to reflect any deviations and changes in scope.

• Conduct post-mortem analyses and supply study metrics to CDM management.

⛳️ Requirements

• A Bachelor’s degree in nursing or life sciences, or an equivalent combination of education and clinical research experience.

• At least 5 years of relevant experience as a Clinical Data Manager in a pharmaceutical or CRO setting.

• A minimum of 2 years of experience with relational databases.

• Familiarity with Medidata Rave, OmniComm, or TrialMaster.

• Outstanding verbal and written communication abilities.

• Understanding of regulatory guidelines.

• Knowledge of medical terminology and drug nomenclature.

• Insight into the drug development and clinical research processes.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health benefits including medical, dental, and vision coverage.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to promote work-life balance.

• A collaborative and inclusive work environment.