Clinical Data 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.

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

KEY RESPONSIBILITIES: 

• Assist in providing support and guidance to junior staff and peers to meet study deliverables within the ICH/GCP guidance.  

• Perform all in-house DM activities, including documentation of vendor-related DM activities (e.g., database build, edit check programming, database modifications). 

• Collaborate with internal teams, which may include 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. 

• May 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 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. 

• Assist in managing 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. 

​ PROFESSIONAL EXPERIENCE/QUALIFICATIONS: 

• Bachelor’s Degree required.

• At least 4 years of clinical data management experience in the pharmace