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.

Innovation Compassion Mathematics Adaptability Life Sciences Test Planning Detail Oriented Microsoft Excel Clinical Trials Problem Solving Quality Control Data Management Data Validation Computer Science Telephone Skills Software Testing Defect Management Acceptance Testing Data Documentation Information Systems Traceability Matrix Microsoft PowerPoint Contingent Workforce Clinical Data Management SQL (Programming Language) Verbal Communication Skills Standard Operating Procedure Python (Programming Language) User Acceptance Testing (UAT) Electronic Data Capture (EDC) Good Clinical Practices (GCP) Continuous Improvement Process Systems Development Life Cycle, 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.

Preferred Experience and Skills:

• 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., Ability to Coordinate, Adaptability, Analytical Problem Solving, Computer Science, Cross-Functional Project Management, Data Documentation, Data Validation, Good Clinical Practice (GCP), Performance Improvements, Software Development Life Cycle (SDLC), Compassion Mathematics Adaptability Life Sciences Test Planning Detail Oriented Microsoft Excel Clinical Trials Problem Solving Quality Control Data Management Data Validation Computer Science Telephone Skills Software Testing Defect Management Acceptance Testing Data Documentation Information Systems Traceability Matrix Microsoft PowerPoint Contingent Workforce Clinical Data Management SQL (Programming Language) Verbal Communication Skills Standard Operating Procedure Python (Programming Language) User Acceptance Testing (UAT) Electronic Data Capture (EDC) Good Clinical Practices (GCP) Continuous Improvement Process Systems Development Life Cycle

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is $71,900.00 - $113,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.