Job Description
📋 Description Support Phase 1-3 trials: activation, conduct, and closeout. Manage TMF setup, maintenance, and QC for inspection-readiness. Collaborate with CROs to review monitoring reports, deviations, and KPIs. Coordinate with internal teams and vendors to meet regulatory requirements. Assist in collection and review of regulatory documentation for initiation. Organize study meetings, logs, and documentation of progress. 🎯 Requirements Bachelor’s degree; life sciences or related degree preferred. 6 months to 1 year of Phase 1-3 clinical trial experience (sponsor or CRO). Proficient in eTMF and CTMS; knowledge of FDA and ICH-GCP. Strong organizational skills, problem solving, and communication. Understanding of clinical drug development; study design. MS Office proficiency (Word, Excel, PowerPoint). 🎁 Benefits Competitive benefits package. Eligible for annual bonus and equity. Opportunity to contribute to pivotal trials and regulatory submissions.
