Senior Clinical Data Manager, Oncology

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 Overview

We are currently seeking a motivated and experienced individual for the position of Senior Clinical Data Manager. The Senior Clinical Data Manager (Sr. CDM) is responsible for leading multiple, high volume and complex studies. They will work closely with senior staff and various operational departments to facilitate accurate and efficient data collection.

Job Duties and Responsibilities

• Assist in providing support and guidance to junior staff and peers to meet study deliverables within the ICH/GCP guidance.
• Perform all inhouse DM activities, including documentation and oversight of vendor-related DM activities (e.g., database build, edit check programming, database modifications).
• Collaborate with internal and external teams, including Clinical Operations, Research, Medical Monitoring, Medical Writing, Clinical Data Management and other operational departments to support data collection efforts.
• Help identify and address operational challenges based on metrics data, audit reports and input from project team members.
• Support the oversight of data management vendors with respect to key performance indicators, metrics, and program level deliverables and timelines.
• Assist in identifying potential Out of Scope activities prior to vendor work, modify/update study contracts while staying within budget, with guidance from senior management as needed.
• Perform Data Management tasks including data processing and quality control, monitor study status, (e.g., Enrollment, eCRFs, Query Aging, etc.) and providing status reports to the team and department throughout the study.
• Contribute to the development of all Data Management documentation for assigned projects including the electronic CRF, Data Management Plan, CRF Completion Guidelines, Data Validation Specification, Data Transfer Specifications, etc.
• Manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements, especially as it pertains to electronic diary data collection and handling.
• Perform thorough development testing of eCRF prior to deployment, inclusive of User Acceptance Test (UAT) Plans, Test Scripts and execute testing applicable.
• Ensure adherence to Data Management standards.
• Perform other activities as required by corporate need.

Key Core Competencies

• Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing, dynamic company
• Results-driven, take initiative and ownership to accomplish work
• Extensive Knowledge of ICH, Good Clinical Practice and FDA regulations
• Strong working knowledge of Medidata Rave
• Experience with elluminate, Microsoft Access, Word, and Excel
• Effective time management and organization skills
• Highly skilled in managing the lifecycle of clinical data projects
• Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes
• Experience with drug development in oncology required
• Strong leadership skills and ability to work within cross-functional teams
• Extensive knowledge in clinical prog