Clinical Trial Manager
G
Generate BiomedicinesBiotechnology
Remote, USFull-TimeMiddle
Salary$127,000 — $178,000 USD
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Job Details
- Experience
- 6+ years
- Required Skills
- GCP
Requirements
- Bachelor’s degree required; scientific or health-related field preferred.
- 6+ years of experience in clinical operations, clinical research, or a related field.
- Foundational understanding of GCP and ICH guidelines.
- Experience working with or alongside CROs or clinical vendors in a coordination capacity.
- Strong attention to detail and ability to manage multiple project trackers and timelines simultaneously.
- Familiarity with clinical trial systems such as CTMS, EDC, and eTMF platforms.
- Clear communication skills with the ability to follow up consistently and escalate issues.
- Ability to travel up to 20% of the time, domestically and/or internationally.
- Prior sponsor-side experience is a plus.
- Familiarity with oncology, immunology, or respiratory therapeutic areas is a plus.
Responsibilities
- Serve as day-to-day operational point of contact for CROs and vendors, tracking deliverables and flagging risks.
- Review study documents for quality, including monitoring reports, protocol deviations, and TMF entries.
- Coordinate study startup activities such as site activation, regulatory document collection, and vendor kick-offs.
- Manage study trackers, timelines, and action logs to provide visibility for cross-functional teams.
- Support safety reporting coordination and ensure timely distribution of SAE/SUSAR notifications.
- Monitor TMF completeness and assist in inspection readiness activities.
- Review CRO-managed study metrics, site performance, and data cleaning progress.
- Support vendor invoice review and budget tracking against contracted activities.
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