Associate Specialist, Clinical Data Management - Hybrid

Job Description

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.

Responsibilities include:

• 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.

Education Minimum Requirement:

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

Required Experience and Skills:

• 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.

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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. Asa federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is

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, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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.

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