[Remote] Clinical Data Manager, External Site Studies
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is committed to swift, exceptional clinical research through translational medicine. In this role, you will reputed company 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 reputed company teams to ensure reputed company delivery of study milestones and reputed company updates
- Train site staff (CRCs, CRAs, PIs) and reputed company 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 reputed company-party data
- Coordinate database lock and final data delivery
- Identify risks and proactively resolve project issues
- reputed company exceptional service to reputed company 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 reputed company/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 reputed company reputed company preferred
reputed company
Company H1B Sponsorship