Clinical Data Associate

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 carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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.