Senior Clinical Trial Manager

Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials. Ensure trial activities comply with protocols, SOPs, GCP, and applicable regulations. Manage and oversee CROs, central labs, biometrics, safety vendors, eTMF providers, and other external partners. Manage, mentor, and support direct reports. Participate in site selection, feasibility assessments, and initiation visits. Build relationships with investigators and site staff to support enrollment and data collection. Oversee development and review of protocols, informed consent forms, CRFs, monitoring plans, and study manuals. Review monitoring reports and ensure timely issue resolution and documented sponsor oversight. Conduct ongoing data reviews and support data cleaning. Maintain inspection readiness, including regular Trial Master File review. Collaborate with finance and legal teams on budgets, invoices, contracts, and change orders. Collaborate with Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and CMC. Provide guidance and mentorship to junior team members and cross-functional colleagues. Prepare study updates, metrics, and presentations for senior leadership. Represent Clinical Operations in internal and external meetings. Contribute to SOPs, work instructions, and operational tools. Travel up to 15% for site visits, vendor meetings, and conferences. Requirements Deep understanding of clinical trial processes. Knowledge of regulatory compliance, including GCP, FDA, and ICH requirements. Experience managing early-phase oncology trials at a sponsor biotech. Ability to lead cross-functional teams. Ability to oversee CROs, vendors, and clinical sites across U.S. and international regions. Ability to ensure high-quality, timely, and cost-effective trial execution. Willingness to travel up to 15%. Core Competencies Demonstrates expertise in managing complex Phase I oncology trials, ensuring compliance with GCP, FDA, and ICH regulations while leading cross-functional teams and overseeing external partners. Capable of maintaining inspection readiness and providing mentorship to junior team members. Highest-signal resume keywords Oncology Trial Management Regulatory Compliance Cross-Functional Team Leadership CRO Oversight Clinical Trial Processes ATS Optimization Keywords Hard Skills Clinical Trial Management Protocol Development Data Review Issue Resolution Budget Management Soft Skills Mentorship Relationship Building Collaboration Communication Industry Keywords GCP FDA ICH Biotech Phase I Trials Tools & Technologies ETMF CRFs Monitoring Plans #J-18808-Ljbffr Jobtailor