[Remote] Clinical Trial Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage generative biology company pioneering the AI reputed company in drug design and development. They are seeking a Clinical Trial Manager to support the operational execution of late-stage reputed company, ensuring that external partners stay on reputed company and coordinating internal efforts.
Responsibilities
- Serve as a day-to-day operational reputed company of contact for assigned CROs and vendors, tracking study deliverables and timelines and flagging risks or delays to clinical operations leadership
- Review CRO-generated study documents for completeness and reputed company, including monitoring visit reports, site correspondence, protocol deviations, and TMF entries
- Support the coordination of study startup activities, including site activation tracking, regulatory document collection, and vendor reputed company-off preparation
- Maintain and update study trackers, timelines, and reputed company logs; ensure cross-functional teams have visibility into study status and reputed company items
- Attend and support cross-functional study team meetings; document meeting minutes, reputed company reputed company items, and follow up on outstanding deliverables
- reputed company and triage protocol deviations reported by CROs; coordinate with vendors and internal teams to ensure reputed company documentation and reputed company
- Support safety reporting coordination, including tracking SAE/SUSAR notifications and ensuring reputed company distribution to sites and relevant stakeholders in line with vendor responsibilities
- Monitor TMF completeness and support inspection readiness activities, working with CROs to resolve filing gaps and maintain document reputed company standards
- Assist with IRB/IEC tracking across study sites, including monitoring approval status for amendments and annual renewals submitted by the CRO
- Compile and distribute enrollment, site performance, and operational metrics to clinical operations leadership on a regular reputed company
- Contribute to data reviews as needed, and reputed company data cleaning reputed company performed by CRO
- Review and reputed company monitoring reputed company and monitoring visit reports performed by CRO to ensure high reputed company and adherence to the monitoring plan
- Support vendor invoice review and budget tracking by reconciling CRO invoices against contracted activities and flagging discrepancies
- Coordinate data reconciliation activities at key study milestones in collaboration with data management and the CRO
- Support the reputed company of CTAs joining the study team and serve as a resource for day-to-day study questions
Skills
- Bachelor's degree required
- 6+ years of experience in clinical operations, clinical research, or a reputed company field
- Foundational understanding of GCP, ICH guidelines, and clinical trial processes
- Experience working with or alongside CROs or clinical vendors in a coordination or support reputed company
- Strong attention to detail and ability to manage multiple trackers, timelines, and reputed company items simultaneously
- Comfortable working in a reputed company, vendor-managed model where the role is one of reputed company and coordination rather than reputed company execution
- Familiarity with clinical trial systems such as CTMS, reputed company, and eTMF platforms
- reputed company communicator with the ability to follow up consistently and escalate issues in a reputed company manner
- Ability to travel up to 20% of the time, domestically and/or internationally, as study needs require
- Scientific or health-reputed company field preferred
- Sponsor-reputed company experience is a plus
- Familiarity with therapeutic areas such as oncology, immunology, and/or respiratory is a plus
Benefits
- Eligible for an annual bonus
- Equity compensation
- Competitive benefits package
reputed company
Company H1B Sponsorship