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WEP Clinical · 1 day ago

Clinical Data Manager

United States

Full-time

Remote

Mid, Senior Level

WEP Clinical is a mission-driven organization dedicated to advancing clinical research and transforming lives. The Clinical Data Manager leads and oversees data management activities for multiple clinical trials, ensuring high-quality data and compliance with regulatory requirements. This role involves managing clinical databases and collaborating with clients to align strategies with their needs.

BiotechnologyInformation TechnologyPharmaceutical

Responsibilities

Lead comprehensive data management activities for multiple clinical trials, ensuring regulatory compliance and data quality

Plan, develop, test, and validate clinical databases and EDC systems to meet trial needs

Collaborate with clients and cross-functional teams on study design, eCRF design, and data cleaning

Monitor and ensure data quality, accuracy, and timely database entries from study sites

Manage external vendors to deliver quality services within project timelines

Maintain regular communication with clients to update on milestones and progress

Ensure adherence to GCP, ICH, and regulatory requirements, supporting audits and inspections

Proactively track study timelines, managing risks and deviations effectively

Contribute to process improvement by developing systems, SOPs, and guidance documents

Support business development activities, including preparing presentations and bid defense materials

Qualification

GCP knowledgeICH guidelines knowledgeClinical database managementData reviewCleaningClinical research experienceMS Office proficiencyStatistics familiarityEffective communicationLeadership skills