(Sr.) Clinical Project Manager-Remote

PRIMARY FUNCTIONWe are seeking a highly motivated Clinical Project Manager (CPM) or Senior Clinical Project Manager (Sr. CPM) to lead the operational execution of early phase global oncology clinical trials across the United States and Europe. This individual will serve as a key member of the global clinical operations team and will work closely with cross functional stakeholders and China based teams to ensure successful delivery of clinical studies from study startup through closeout.The ideal candidate is a proactive and collaborative clinical operations professional with strong project management capabilities, oncology experience, and demonstrated success managing CROs, vendors, timelines, budgets, and study execution in a fast-paced biotech environment.This role requires flexibility in working hours to support effective collaboration with global teams across multiple time zones, including China.MAJOR RESPONSIBILITIES AND DUTIESLead the operational execution and oversight of early phase global oncology clinical trials from study startup through database lock and study closeout. Develop and maintain comprehensive study timelines, operational plans, enrollment projections, risk assessments, and study tracking tools. Ensure studies are conducted in compliance with ICH/GCP guidelines, company SOPs, applicable regulatory requirements, and study protocols. Drive study deliverables, milestones, and timelines while proactively identifying and mitigating operational risks and issues. Support protocol review and development activities and provide operational input into study design and execution strategies. Build and maintain strong relationships with investigators, study sites, CROs, and external vendors. Lead cross functional study teams and facilitate effective communication across Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Pharmacovigilance, Regulatory, CMC, and other functional groups. Provide leadership, guidance, and oversight to direct reports, CRAs, CROs, and study vendors. Oversee CRO performance and vendor activities to ensure high quality study execution and compliance with contractual obligations and KPIs. Participate in vendor selection, bid review, contract/SOW development, and vendor governance activities. Review monitoring reports, study metrics, enrollment trends, and operational performance indicators to ensure study quality and progress. Escalate study risks and issues appropriately and drive timely resolution. Manage study budgets, forecasting, accruals, and resource planning throughout the clinical trial lifecycle. Track study expenses and provide regular updates on budget status, projections, and financial risks. Support strategic operational planning and resource allocation for assigned programs. Ensure Trial Master File (TMF) completeness, quality, and inspection readiness throughout the study lifecycle. Support audit and regulatory inspection activities and contribute to inspection readiness planning. Identify operational quality issues and support development and implementation of corrective and preventive actions (CAPAs) as needed. Promote a culture of quality, compliance, and continuous improvement across study teams. QUALIFICATIONSBachelor’s degree in Life Sciences, Pharmacy, Clinical Medicine, or related scientific discipline. Advanced degree (MS, PharmD, PhD, or MD) a plus.Minimum of 5 years of relevant industry experience for Clinical Project Manager level Prior oncology clinical trial experience required, including experience supporting early phase studies. Demonstrated experience managing global clinical trials in the US and Europe. Strong knowledge of ICH/GCP guidelines, FDA/EMA regulations, and clinical trial operations. Proven experience managing CROs, vendors, study budgets, timelines, and cross functional teams. Strong leadership, organizational, project management, and problem solving skills. Excellent verbal and written communication skills with the ability to effectively collaborate across global teams and cultures. Ability to work flexibly across time zones to support collaboration with China based teams. Experience in fast-paced biotech or emerging pharmaceutical environments. Familiarity with Veeva Vault TMF, Medidata Rave, CTMS, and other clinical systems. Experience supporting regulatory inspections and audit readiness activities. Able to travel up to 25%.