Senior Study Manager Position Available In Morris, New Jersey

Job Title:

Senior Study Manager Job Description The Senior Study Manager will play a pivotal role in managing and delivering clinical studies focused on ovarian cancer trials across multiple geographic regions. The position involves overseeing large global Phase III clinical trials, ensuring compliance with international standards and guidelines. The role requires a proactive approach in study planning and execution, with a strong emphasis on collaboration and communication with internal and external stakeholders. Responsibilities Ensure the delivery execution of clinical studies in adherence to GCPs, SOPs, FDA regulations, EU Directive, and ICH guidelines. Communicate project status, escalate issues, and troubleshoot routine inquiries with key stakeholders. Lead the development of clinical study plans, including critical path activities and interdependencies utilizing Microsoft Project. Create and manage the cross-functional Clinical Study Oversight Plan, ensuring adherence and managing implementation and documentation. Provide operational input into study protocol profiles and amendments. Lead document review and coordination for protocol and amendments, and oversee additional medical writing tasks. Coordinate the CRO and vendor selection process in collaboration with the study team. Monitor clinical trial performance and quality metrics, ensuring actions are taken and issues are escalated appropriately. Assess potential risks to the study and propose mitigation plans. Monitor study budget against trial progress, reviewing and approving vendor invoices, and ensuring reconciliation with Finance. Oversee the performance and management of CROs and 3rd party vendors to ensure compliance with quality measures. Track operational study timelines and monitor performance metrics, identifying issues and proposing solutions. Coordinate operational activities with the CRO, supporting interim analysis and database lock. Oversee CRO study close-out activities, ensuring completion of drug destruction processes and other study close-out tasks. Support department in codifying existing knowledge and best practices, preparing training in areas of expertise. Essential Skills 7+ years of global trial management experience within oncology in the pharmaceutical industry. Experience in solid tumor oncology, with gynecological experience highly preferred. Vendor/CRO oversight expertise, managing engagement with up to 8-12 vendors. Extensive global experience across all regions. Ability to anticipate project needs and be proactive in early stages of study planning. Experience working with Cooperative groups. Additional Skills & Qualifications Ability to adapt quickly to a fast-paced environment. Strong collaborative skills. Excellent written and oral communication skills. Work Environment This is a 100% remote role, requiring candidates to be in the Eastern Time Zone or local to the

NJ/PA/NY

area. Flexibility for face-to-face meetings is preferred.