Associate, Clinical Project Manager

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Duties and Responsibilities

• Supports the CPM to design, develop, and deliver the clinical study per agreed upon timelines. 
• Assists in the planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data. 
• Monitors the status of clinical data collection of assigned clinical trials 
• Assists with preparation of potential investigator site lists and assists with their evaluation for inclusion in the study 
• Prepares and reviews study-related plans and documents when required 
• Reviews study-related plans generated by CROs and vendors, and ensures the documents are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies 
• Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required 
• Participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training 
• Prepares and delivers program/study updates as determined by project team 
• Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members 
• Supports CPM with review of change orders from CROs, vendors and investigator sites (as applicable). 
• Provides input into contracts, work orders and/or change orders 
• Assists with review and management of invoice tracking/reconciliation 
• Ability to anticipate potential study issues and to prepare contingency plans in consultation with the CPM 
• Supports the CPM to ensure assigned studies adhere to all applicable regulations and requirements 
• Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates 
• Identifies issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and supports implementation of solutions and mitigations in consultation with the CPM 
• Participates in the preparation, review, updating and training of SOPs 
• Maintains knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in orde