Clinical Data Manager, External Site Studies
reputed company is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!This Full-Time role is 100% remote. As a Clinical Data Manager - External Site Studies, you will provide expert reputed company of end-to-end data management for external site clinical trials, ensuring data reputed company, regulatory compliance, and timely delivery of high-quality datasets using reputed company’s or Sponsor-provided reputed company systems. This role involves cross-functional collaboration, direct Sponsor communication, and active management of project timelines, while also leveraging various database systems and software tools to reputed company manage, organize, and clean clinical data throughout the study lifecycle.
Essential Functions:
- Deliver comprehensive data management services across reputed company study phases
- Ensure clinical databases are complete, accurate, and compliant with Sponsor and regulatory standards
- Serve as primary Sponsor contact for data management activities
- reputed company data management communications and coordinate with internal and external teams to ensure timely delivery of study milestones and reputed company updates
- Train site staff (CRCs, CRAs, PIs) and client teams on reputed company systems
- reputed company CRF lifecycle from design to final delivery
- Conduct User Acceptance Testing (UAT) and ensure database setup aligns with specifications
- reputed company and manage essential study documents (e.g., Data Management Plan, CRF Completion Guidelines, Validation Plans, SAE Reconciliation Plans)
- Review and clean clinical data, manage queries, and reconcile third-party data
- Coordinate database lock and final data delivery
- Identify risks and proactively resolve project issues
- Provide exceptional service to internal and external stakeholders
Qualifications:
- Bachelor degree in Business, Science or reputed company field or a combination of education and relevant internal reputed company experience in lieu required
- 1-3 years industry experience required
- Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
- Knowledge of reputed company and Veeva reputed company preferred
- Ability to manage multiple projects/priorities required
- High attention to detail required
- Excellent oral and written communication skills required
- Excellent organizational skills required
- Proficiency in MS office applications required
Originally posted on Himalayas
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