Associate Specialist, Clinical Data Management - Hybrid

The Associate Clinical Data Management Analyst supports the testing and validation of clinical data management systems and applications used in clinical trials. The individual works in accordance with company Software Development Lifecycle (SDLC) requirements, Good Testing Practices, Standard Operating Procedures (SOPs), and ICH-GCP guidelines.

• Support the creation and execution of Quality Control (QC) Testing and User Acceptance Testing (UAT) procedures for clinical data management systems and applications.
• Participate in the testing and validation of Electronic Data Capture (EDC) systems, electronic diaries, electronic devices, IVRS/IWRS systems, in-life data review reports, and other clinical data management technologies.
• Assist with the creation, review, and maintenance of test documentation, including test plans, test scripts, traceability matrices, and testing evidence.
• Collaborate with Clinical Data Management, Programming, Standards, and technical teams to ensure test requirements are clearly understood and appropriately implemented.
• Support the review and verification of database configurations, edit checks, reports, data transfers, and system functionality.
• Identify, document, and communicate testing issues and support resolution activities.
• Contribute to project deliverables while ensuring compliance with SDLC requirements, SOPs, and applicable regulatory expectations.
• Develop knowledge of clinical data management processes, clinical trial systems, and validation methodologies.
• Participate in departmental initiatives and continuous improvement activities as assigned.

• B.A. or B.S. degree, preferably in Mathematics, Computer Science, Life Sciences, Health Care, Information Systems, or a related discipline.

• Basic understanding of Software Development Lifecycle (SDLC) and system validation.
• Strong attention to detail and focus on quality.
• Good written and verbal communication skills.
• Strong organizational, analytical, and problem-solving skills.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Proficiency in Microsoft Office (Excel, Word, and PowerPoint).
• Ability to manage multiple priorities in a dynamic environment.

• Knowledge of Electronic Data Capture (EDC) systems and clinical databases.
• Understanding of software testing methodologies and defect management processes.
• Familiarity with database concepts and data management principles.
• Experience developing or executing test scripts.
• Knowledge of GxP, ICH-GCP, or related regulatory requirements.
• Ability to learn new technologies and processes quickly.
• Knowledge in SQL, Python, automation tools, and Generative AI technologies.

US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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The salary range for this role is $71,900.00 - $. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications