Senior Manager, Clinical Data Management

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

📋 Description

• Act as the primary data manager for designated clinical studies and programs, formulating and sustaining study-specific data management strategies, timelines, and deliverables.

• Evaluate and authorize Data Management Plans, Data Validation Plans, edit check specifications, eCRF specifications, and documentation related to database builds.

• Provide direct oversight for Medidata Rave EDC database builds, including eCRFs, edit checks, custom functions, workflows, and associated configurations.

• Generate, execute, review, and analyze Rave reports and listings to facilitate data review, cleaning, reconciliation, and oversight.

• Plan, execute, and document testing of database constructs, edit checks, eCRFs, derivations, and system functionality; identify defects, evaluate impact, monitor resolutions, and confirm fixes through UAT.

• Lead data evaluation, query management, external data reconciliation, and database lock operations, including supervision of CRO and vendor deliverables.

• Oversee data quality, metrics, and study timelines to proactively identify risks; assist with external data integrations, transfer specifications, reconciliation tasks, and inspection readiness.

• Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, and external vendors during the study process.

• Provide updates on data management tasks, risks, decisions, and timelines, and escalate issues as necessary.

• Review CRO financial documentation, change notifications, and data management expenditures for oversight of scope, budget, and timelines.

• Contribute to the ongoing enhancement of data management processes, standards, tools, and templates.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related field.

• A minimum of 7+ years of experience in clinical data management within the pharmaceutical, biotechnology, or CRO sectors.

• Required practical experience with Medidata Rave EDC, eCOA, and RTSM.

• Proven experience in creating, executing, reviewing, and interpreting Medidata Rave reports and listings.

• Demonstrated expertise in testing clinical database builds, UAT scripts, edit checks, eCRFs, and database modifications, including defect documentation and retesting.

• Strong understanding of database design, edit checks, data review, query management, external data reconciliation, and database locking processes.

• Comprehensive knowledge of ICH-GCP and relevant regulatory requirements.

• Experience in reviewing CRO study financial reports, change notifications, and data management expenses.

• Exceptional written, verbal, and interpersonal communication skills.

• Strong organizational and prioritization capabilities, with the ability to multitask, manage conflicting deadlines, and maintain meticulous attention to detail.

🏝️ Benefits

• Annual bonus

• Equity compensation

• Competitive benefits package

• Equal employment opportunity