Clinical Study Lead (CSL)

Clinical Study Lead (CSL) - (Warren, NJ, Armonk NY or Cambridge, MA) Warren, NJ, Armonk NY or Cambridge, MA Opportunity Details On Assignment Clinical Study Lead (CSL) - (Warren, NJ, Armonk NY or Cambridge, MA) KPS Life is hiring a Clinical Study Lead to be fully dedicated to our sponsor partner and work 3 days a week in one of their offices located in Armonk, NY, Warren, NJ or Cambridge MA. KPS Life is hiring a Clinical Study Lead to be fully dedicated to our sponsor partner and work 3 days a week in one of their offices located in Armonk, NY, Warren, NJ or Cambridge MA. This role offers the opportunity to lead complex global clinical trials from planning through closeout, overseeing study execution, cross-functional teams, CROs, budgets, timelines, and quality. We’re looking for an experienced clinical operations professional with at least 5+ year experience in study leadership, vendor management, and global trial experience. Clinical Study Lead (CSL) Global Clinical Operations | Hybrid | Armonk, NY • Warren, NJ • Cambridge, MA Position Overview The Clinical Study Lead (CSL) supports the global execution of large and/or complex clinical trials from study design through closeout. This role leads cross-functional study teams and oversees study timelines, budgets, quality, and compliance with SOPs and ICH-GCP requirements. Responsibilities include both direct study leadership and oversight of CRO-managed studies. Key Responsibilities Study Leadership & Strategy Lead cross-functional study teams and serve as a key point of contact for study leadership and oversight. Provide operational input into protocol development and key study documents. Lead feasibility assessments, country selection, site evaluation, and investigator meetings. Study Execution & Delivery Oversee study timelines, milestones, site activation, monitoring progress, recruitment, and retention strategies. Manage study budgets, vendor contracts, scope changes, and clinical supplies forecasting. Oversee study systems, including CTMS and TMF, and ensure timely data entry and query resolution. Lead study-level risk assessments and implement mitigation strategies. Monitor data quality, protocol deviations, site compliance, and study performance metrics. Support audit and inspection readiness, CAPAs, and compliance with ICH-GCP and regulatory requirements. Lead vendor engagement and oversee CRO and third-party vendor performance. Escalate study issues and drive resolution of risks affecting quality, timelines, or budgets. Oversee closeout activities, including database lock, TMF completion, drug accountability, and clinical study report review. Support Clinical Study Management staff and contribute to lessons learned. Requirements & Qualifications Bachelor's degree or equivalent and at least 5+ years of relevant industry experience; an advanced degree may be considered in lieu of relevant experience. Experience in global clinical trial operations, including protocol development and key study documentation. Demonstrated cross-functional team leadership, project management, and organizational skills. Proven vendor management and budget management experience. Strong understanding of ICH-GCP and applicable regulatory guidelines. Technical proficiency with clinical trial systems, including CTMS, EDC, IWRS/IVRS, and Microsoft applications such as Teams, Office, and Project. Strong communication, presentation, interpersonal, negotiation, and influencing skills. Data-driven approach to planning, problem-solving, and decision-making, with the ability to prioritize and meet deadlines. Ability to build productive teams, manage competing priorities, and stay current with industry trends. #J-18808-Ljbffr Kps-Life