Manager, Clinical Study Lead

Responsibilities Accountable for global execution of assigned smaller/less complex clinical trials from study design through execution to close out; own study timelines and budget and ensure conduct per SOPs and ICH/GCP. Lead cross‑functional study team and oversee delivery vs. timelines, deliverables, and budget; raise issues (conduct, quality, timelines, budget) and implement corrective actions. Provide operational input into protocol development; lead feasibility assessments; oversee/conduct site evaluation and selection; lead investigator meeting preparation and execution. Oversee/contribute to study documentation (e.g., CRFs, data management plan, monitoring plan/oversight plan, training plan, data review plan, statistical analysis plan). Oversee setup/maintenance of study systems (CTMS, TMF) and compliance with trial registry requirements. Identify outsourcing needs; lead vendor engagement, contracting, and management; ensure CRO/third parties deliver per scope. Lead study‑level risk assessment/mitigation; monitor site activation/visits; oversee recruitment/retention strategies; monitor data entry and query resolution. Manage study close‑out (database lock, vendor contract/budget/TMF reconciliation, drug accountability); contribute to CSR writing/review; facilitate lessons learned. Supervise CTM staff and assign tasks; recommend process improvements and continuous improvements to CTM SOPs. Qualifications Bachelor’s degree; 6+ years relevant industry experience. Extensive budget, vendor, and study team‑building experience. Technical proficiency with trial management systems and Microsoft (Project, PowerPoint, Word, Excel); IVRS/IWRS and EDC. Global clinical trial operations experience; protocol/document development; strong ICH/GCP and regulatory knowledge; project management and cross‑functional leadership. Skills/Requirements Understand and implement operational strategic direction for clinical studies. Location/Work Armonk, NY; Warren, NJ; Uxbridge, UK; hybrid (4 days/week on site); up to 25% travel. Benefits (as stated) Health/wellness programs Fitness centers 401(k) match Equity awards Annual bonuses Paid time off Paid leaves #J-18808-Ljbffr