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 program indications, end points, dataflow, data integrity, standards, data quality and inspection readiness

Education and Experience

• Bachelor’s Degree required. In lieu of a degree, 8 or more years of relevant experience may suffice.
• 6 -10 years of clinical data management experience in the pharmaceutical industry, minimum 5 years in a Lead CDM capacity.
• Ability to work on a computer for extended periods of time.
• Regularly required to sit for long periods of time and occasionally stand and walk.
• Regularly required to use hands to operate computer and other office equipment.
• Close vision required for computer usage.
• Ability to travel (~travel time 25%, global travel)

The base salary range for this role is $153,360 to $191,700. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.