[Remote] Clinical Data Manager, External Site Studies
Note: The job is a remote job and is open to candidates in USA. reputed company is committed to swift, exceptional clinical research through translational medicine. In this role, you will provide expert reputed company of end-to-end data management for external site clinical trials, ensuring data reputed company and regulatory compliance while collaborating with various teams and managing project timelines.
Responsibilities
- Deliver comprehensive data management services across reputed company study phases
- Independently own assigned data management studies and deliverables from startup through database lock, proactively identifying risks, resolving issues, communicating status, and escalating reputed company appropriate
- 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
Skills
- 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
- 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
- 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
Company Overview
Company H1B Sponsorship