Clinical Data Associate

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.

KEY RESPONSIBILITIES:

• Generate and close data queries according to the relevant guidelines (Integrated Data Review Plan/ Data Validation Specification)
• Assist in the development and maintenance of key documents including manual data checks, CRF completion guidelines, programmed edit checks, and Data Management Plans (DMP)
• Create reports and provide updates on study metrics
• Assist in creation and review of User Acceptance Test plans and test scripts
• Update and help maintain eTMF with DM study related documentation
• Conduct in-house data review and provide feedback to LCDM
• Conduct reconciliation of SAEs and send out queries as required and notify relevant Safety Groups of possible issues for their action 
• Support Lab Normal Range management for studies with local labs    
• Ensure all clinical data management procedures are executed with a high attention to detail, accuracy and within timelines provided
• Assist LCDM with cleaning data for Interim Analysis, Database Lock, and any ad hoc requests
• Train team members on selected tasks
• Ensure adherence to Clinical Data Management standards
• Perform other duties as assigned

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PROFESSIONAL EXPERIENCE/QUALIFICATIONS:

• Bachelor’s degree in life sciences or related field or Associate’s degree with at least one year of relevant experience
• 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.

The base salary range for this role is $51,000 to $63,800.  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